Clinical Research Coordinator II - Nurse

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

We are seeking a full-time, experienced Clinical Research Coordinator - Level II (CRC II). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.  

Responsibilities:

• Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication  and protocol management. Able to manage an increased number of studies and/or more complex studies
• Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation to meet enrollment targets on assigned studies
• Schedule all patient research visits and procedures consistent with protocol requirements
• Conduct patient visits as outlined within each study protocol
• Dispense study medication, collect vital signs and perform ECGs
• Perform blood draws, process and ship specimens per study protocol and IATA regulations
• If assigned, place IVs, administer IV medication, and fluids according to protocol. Monitor patients’ IV medications and tubing. Give intramuscular and subcutaneous injections according to protocol. Monitor patients during infusion and discharge patients as policies indicate.
• Ensure relevant study and subject specific information is entered into the CTMS system on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms. 
• Act as point of contact for study participants
• Adhere to Research SOPs, Good Clinical Practices, and the study protocols
• Maintain ongoing communication with the CRO, sponsor, research participants, Site  Manager and PI throughout course of the study
• Ensure all safety data is reviewed by the PI in a timely manner
• Maintain inventory of study equipment and supplies onsite at all times
• Participate actively in communication of status and results to management; contribute and implement ideas to improve site performance 
• Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol. Meet requirements for data query resolution times and quality
• Schedule and prepare for monitor visits
• Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance 
• Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy

Iterative Health Expectations

All employees are expected to:  

• Perform quality work within deadlines with or without direct supervision
• Interact professionally with other employees, customers and suppliers
• Work effectively as a team contributor on all assignments
• Work independently while understanding the necessity for communicating and  coordinating work efforts with other employees and organizations

Qualifications

• Registered Nurse
• Solid nursing background, concentration, or willingness to obtain advanced knowledge in GI specialty
• Minimum 3 years of clinical research experience
• Ability to own issues and problem solve independently 
• Experience in phlebotomy preferred
• Strong written and verbal communication skils
• Ability to read, interpret, and apply clinic policies and research protocols
• Ability to use standard office software
• Must be able to lift up to 25 pounds

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Clinical Research Coordinator I

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

We are seeking a full-time, experienced Clinical Research Coordinator (CRC). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.  

Responsibilities:

• Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication  and protocol management. 
• Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation
• Schedule all patient research visits and procedures consistent with protocol requirements
• Conduct patient visits as outlined within each study protocol
• Dispense study medication, collect vital signs and perform ECGs
• Perform blood draws, process and ship specimens per study protocol and IATA regulations
• Ensure relevant study and subject specific information is entered into the CTMS system  on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms. 
• Act as point of contact for study participants
• Adhere to Research SOPs, Good Clinical Practices, and the study protocols
• Maintain ongoing communication with the CRO, sponsor, research participants, Site  Manager and PI throughout course of the study
• Ensure all safety data is reviewed by the PI in a timely manner 
• Maintain inventory of study equipment and supplies onsite at all times
• Participate actively in communication of status and results to management 
• Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol
• Schedule and prepare for monitor visits
• Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance 
• Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy

Iterative Health Expectations

All employees are expected to:  

• Perform quality work within deadlines with or without direct supervision
• Interact professionally with other employees, customers and suppliers
• Work effectively as a team contributor on all assignments
• Work independently while understanding the necessity for communicating and  coordinating work efforts with other employees and organizations

Qualifications

• Medical Assistant, LPN, Associates or Bachelor’s degree in a clinical or scientific-related discipline preferred
• Minimum 1-2 years of clinical research experience
• Able to execute on research tasks with guidance from more experienced staff, PIs, and management
• Strong written and verbal communication skils
• Ability to read, interpret, and apply clinic policies and research protocols
• Ability to use standard office software
• Must be able to lift up to 25 pounds

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Clinical Research Coordinator II

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

We are seeking a full-time, experienced Clinical Research Coordinator - Level II (CRC II). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.  

Responsibilities:

• Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication and protocol management. Manage a full schedule of complex study visits and corresponding tasks with minimal direction. 
• Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation to meet enrollment targets on assigned studies, with accountability for achieving enrollment goals
• Schedule all patient research visits and procedures consistent with protocol requirements
• Conduct patient visits as outlined within each study protocol
• Dispense study medication, collect vital signs and perform ECGs
• Perform blood draws, process and ship specimens per study protocol and IATA regulations
• Ensure relevant study and subject specific information is entered into the CTMS system on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms. Maintain high quality data entry within established timelines
• Act as point of contact for study participants
• Adhere to Research SOPs, Good Clinical Practices, and the study protocols
• Maintain ongoing communication with the CRO, sponsor, research participants, Site  Manager, central Iterative Health team, and PI throughout the study. Resolve routine sponsor and CRO issues independently
• Ensure all safety data is reviewed by the PI in a timely manner
• Maintain inventory of study equipment and supplies onsite at all times
• Contribute to status updates to management; contribute and implement ideas to improve site performance 
• Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol. Meet requirements for data query resolution times and quality. 
• Schedule and prepare for monitor visits
• Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance 
• Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy

Iterative Health Expectations

All employees are expected to:  

• Perform quality work within deadlines with or without direct supervision
• Interact professionally with other employees, customers and suppliers
• Work effectively as a team contributor on all assignments
• Work independently while understanding the necessity for communicating and  coordinating work efforts with other employees and organizations

Qualifications

• Medical Assistant, LPN, Associates or Bachelor’s degree in a clinical or scientific-related discipline preferred
• Minimum 3 years of clinical research experience
• Ability to own issues and problem solve independently 
• Experience in phlebotomy preferred
• Strong written and verbal communication skils
• Ability to read, interpret, and apply clinic policies and research protocols
• Ability to use standard office software
• Must be able to lift up to 25 pounds

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Clinical Research Coordinator II

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

We are seeking a full-time, experienced Clinical Research Coordinator - Level II (CRC II). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.  

Responsibilities:

• Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication and protocol management. Manage a full schedule of complex study visits and corresponding tasks with minimal direction. 
• Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation to meet enrollment targets on assigned studies, with accountability for achieving enrollment goals
• Schedule all patient research visits and procedures consistent with protocol requirements
• Conduct patient visits as outlined within each study protocol
• Dispense study medication, collect vital signs and perform ECGs
• Perform blood draws, process and ship specimens per study protocol and IATA regulations
• Ensure relevant study and subject specific information is entered into the CTMS system on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms. Maintain high quality data entry within established timelines
• Act as point of contact for study participants
• Adhere to Research SOPs, Good Clinical Practices, and the study protocols
• Maintain ongoing communication with the CRO, sponsor, research participants, Site  Manager, central Iterative Health team, and PI throughout the study. Resolve routine sponsor and CRO issues independently
• Ensure all safety data is reviewed by the PI in a timely manner
• Maintain inventory of study equipment and supplies onsite at all times
• Contribute to status updates to management; contribute and implement ideas to improve site performance 
• Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol. Meet requirements for data query resolution times and quality. 
• Schedule and prepare for monitor visits
• Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance 
• Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy

Iterative Health Expectations

All employees are expected to:  

• Perform quality work within deadlines with or without direct supervision
• Interact professionally with other employees, customers and suppliers
• Work effectively as a team contributor on all assignments
• Work independently while understanding the necessity for communicating and  coordinating work efforts with other employees and organizations

Qualifications

• Medical Assistant, LPN, Associates or Bachelor’s degree in a clinical or scientific-related discipline preferred
• Minimum 3 years of clinical research experience
• Ability to own issues and problem solve independently 
• Experience in phlebotomy preferred
• Strong written and verbal communication skils
• Ability to read, interpret, and apply clinic policies and research protocols
• Ability to use standard office software
• Must be able to lift up to 25 pounds

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Research Assistant

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

We are seeking a full-time, on-site Research Assistant (RA). The RA is a specialized research professional working with and under the direction of the Clinical Principal Investigator (PI) and site management. The primary responsibility of the RA is to assist the Clinical Research  Coordinators with conduct of research studies. The RA supports and facilitates the daily  clinical trial activities and plays a supportive role in the conduct of the study. 

Responsibilities

• Assists Study Team with communicating study requirements to all individuals involved in the study
• Works with the Study Team to develop and implement recruitment strategies in accordance with site policies and IRB requirements and approvals
• Assists Study Team with screening subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion
• Assists Study Team as requested to register participants in the Clinical Trial Management System to ensure billing of study procedures to appropriate funding source
• Maintains inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or site policies on Investigational Drug/Device Accountability
• Assists Study Team in completing study documentation and maintenance of study files in accordance with sponsor requirements and site policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms
• Aids the Study Team in maintaining effective and ongoing communication with sponsor, research participants, site management and PI during the course of the study
• Works with the Study Team to manage the day to day activities of the study including problem solving, communication and protocol management
• Collects and reports ongoing patient recruitment/ enrollment progress and metrics to site management and PI
• As directed, process and ship specimens per study protocol and IATA regulations
• Arranges secure storage of study documents that will be maintained according to Good Clinical Practice guidelines or for the contracted length of time, whichever is longer
• Enter all patient visit data in e-CRF and CTMS on a daily basis or as directed
• Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance 
• Other duties as assigned

Iterative Health Expectations

All employees are expected to:  

• Perform quality work within deadlines with or without direct supervision
• Interact professionally with other employees, customers and suppliers
• Work effectively as a team contributor on all assignments
• Work independently while understanding the necessity for communicating and  coordinating work efforts with other employees and organizations

Qualifications

• High school diploma or equivalent. Some college preferred
• Minimum 2 years in a healthcare setting
• Strong written and verbal communication skils
• Ability to read, interpret, and apply clinic policies and research protocols
• Ability to use standard office software
• Must be able to lift up to 25 pounds

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Clinical Research Coordinator I

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

We are seeking a full-time, experienced Clinical Research Coordinator (CRC). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.  

Responsibilities:

• Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication and protocol management. 
• Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation
• Schedule all patient research visits and procedures consistent with protocol requirements
• Conduct patient visits as outlined within each study protocol
• Dispense study medication, collect vital signs and perform ECGs
• Perform blood draws, process and ship specimens per study protocol and IATA regulations
• Ensure relevant study and subject specific information is entered into the CTMS system  on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms. 
• Act as point of contact for study participants
• Adhere to Research SOPs, Good Clinical Practices, and the study protocols
• Maintain ongoing communication with the CRO, sponsor, research participants, Site  Manager and PI throughout course of the study
• Ensure all safety data is reviewed by the PI in a timely manner 
• Maintain inventory of study equipment and supplies onsite at all times
• Participate actively in communication of status and results to management 
• Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol
• Schedule and prepare for monitor visits
• Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance 
• Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy

Iterative Health Expectations

All employees are expected to:  

• Perform quality work within deadlines with or without direct supervision
• Interact professionally with other employees, customers and suppliers
• Work effectively as a team contributor on all assignments
• Work independently while understanding the necessity for communicating and  coordinating work efforts with other employees and organizations

Qualifications

• Medical Assistant, LPN, Associates or Bachelor’s degree in a clinical or scientific-related discipline preferred
• Minimum 1-2 years of clinical research experience
• Able to execute on research tasks with guidance from more experienced staff, PIs, and management
• Strong written and verbal communication skils
• Ability to read, interpret, and apply clinic policies and research protocols
• Ability to use standard office software
• Must be able to lift up to 25 pounds

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Clinical Research Coordinator II

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

We are seeking a full-time, experienced Clinical Research Coordinator - Level II (CRC II). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.  

Responsibilities:

• Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication  and protocol management. 
• Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation to meet enrollment targets on assigned studies
• Schedule all patient research visits and procedures consistent with protocol requirements
• Conduct patient visits as outlined within each study protocol
• Dispense study medication, collect vital signs and perform ECGs
• Perform blood draws, process and ship specimens per study protocol and IATA regulations
• Ensure relevant study and subject specific information is entered into the CTMS system  on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms. 
• Act as point of contact for study participants
• Adhere to Research SOPs, Good Clinical Practices, and the study protocols
• Maintain ongoing communication with the CRO, sponsor, research participants, Site  Manager and PI throughout course of the study
• Ensure all safety data is reviewed by the PI in a timely manner
• Maintain inventory of study equipment and supplies onsite at all times
• Participate actively in communication of status and results to management; contribute and implement ideas to improve site performance 
• Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol. Meet requirements for data query resolution times and quality
• Schedule and prepare for monitor visits
• Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance 
• Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy

Iterative Health Expectations

All employees are expected to:  

• Perform quality work within deadlines with or without direct supervision
• Interact professionally with other employees, customers and suppliers
• Work effectively as a team contributor on all assignments
• Work independently while understanding the necessity for communicating and  coordinating work efforts with other employees and organizations

Qualifications

• Medical Assistant, LPN, Associates or Bachelor’s degree in a clinical or scientific-related discipline preferred
• Minimum 3 years of clinical research experience
• Experience in phlebotomy preferred
• Strong written and verbal communication skils
• Ability to read, interpret, and apply clinic policies and research protocols
• Ability to use standard office software
• Must be able to lift up to 25 pounds

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Clinical Research Coordinator II - Nurse

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

We are seeking a full-time, experienced Clinical Research Coordinator - Level II (CRC II). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.  

Responsibilities:

• Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication and protocol management. Manage a full schedule of complex study visits and corresponding tasks with minimal direction. 
• Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation to meet enrollment targets on assigned studies, with accountability for achieving enrollment goals
• Schedule all patient research visits and procedures consistent with protocol requirements
• Conduct patient visits as outlined within each study protocol
• Dispense study medication, collect vital signs and perform ECGs
• Perform blood draws, process and ship specimens per study protocol and IATA regulations
• If assigned, place IVs, administer IV medication, and fluids according to protocol. Monitor patients’ IV medications and tubing. Give intramuscular and subcutaneous injections according to protocol. Monitor patients during infusion and discharge patients as policies indicate.
• Ensure relevant study and subject specific information is entered into the CTMS system  on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms. 
• Act as point of contact for study participants
• Adhere to Research SOPs, Good Clinical Practices, and the study protocols
• Maintain ongoing communication with the CRO, sponsor, research participants, Site  Manager and PI throughout course of the study
• Ensure all safety data is reviewed by the PI in a timely manner
• Maintain inventory of study equipment and supplies onsite at all times
• Support other site staff with coaching on best practices for clinical trials processes, patient interactions, data integrity, sponsor communication, and project management
• Work closely with Principal Investigators and referring positions to build understanding and enthusiasm for research opportunities for patients
• Participate actively in communication of status and results to management; contribute and implement ideas to improve site performance related to enrollment, screen fails, and protocol adherence  
• Assess problem situations to identify causes, gather and process relevant information,  generate possible solutions; make recommendations to management to resolve the situations
• Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol. Meet requirements for data query resolution times and quality
• Schedule and prepare for monitor visits
• Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance 
• Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy

Iterative Health Expectations

All employees are expected to:  

• Perform quality work within deadlines with or without direct supervision
• Interact professionally with other employees, customers and suppliers
• Work effectively as a team contributor on all assignments
• Work independently while understanding the necessity for communicating and  coordinating work efforts with other employees and organizations

Qualifications

• Registered Nurse
• Solid nursing background, concentration, or willingness to obtain advanced knowledge in GI specialty
• Minimum 3 years of clinical research experience
• Ability to own issues and problem solve independently 
• Experience in phlebotomy preferred
• Strong written and verbal communication skils
• Ability to read, interpret, and apply clinic policies and research protocols
• Ability to use standard office software
• Must be able to lift up to 25 pounds

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Research Intern

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

We are seeking a full-time, on-site Research Intern. The Intern is a specialized research professional working with and under the direction of the Clinical Principal Investigator (PI) and site management. The primary responsibility of the Intern is to assist the Clinical Research  Coordinators with conduct of research studies. The Intern supports and facilitates the daily clinical trial activities and plays a supportive role in the conduct of the study, especially related to patient eligibility and recruitment

Responsibilities

• Assist clinical research staff with reviewing protocols for patient eligibility criteria
• Assist with managing recruitment and referral networks, screening subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion and prioritizing patients for outreach and follow up
• Learn to navigate various databases and referral sources for patients, including the Electronic Medical Record (EMR) and other clinical databases
• Document patient information in the Clinical Trials Management System
• Works with the Study Team to develop and implement recruitment strategies in accordance with site policies and IRB requirements and approvals
• Under guidance from research staff, become proficient in navigating research, study protocols, and chart reviews to complete the above tasks
• Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance
• Other duties as assigned

Iterative Health Expectations

All employees are expected to: 

• Perform quality work within deadlines with or without direct supervision
• Interact professionally with other employees, customers and suppliers
• Work effectively as a team contributor on all assignments
• Work independently while understanding the necessity for communicating and  coordinating work efforts with other employees and organizations

Qualifications

• High school diploma or equivalent. Some college preferred
• Strong written and verbal communication skils
• Ability to read, interpret, and apply clinic policies and research protocols
• Ability to use standard office software
• Must be able to lift up to 25 pounds

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

We are seeking a full-time, experienced Clinical Research Coordinator - Nurse. The CRC-RN supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. 

Responsibilities/Duties/Functions/Tasks:

• Communicate study requirements to all individuals involved in the study.  
• Develop and implement recruitment strategies in accordance with GI Alliance RESEARCH and IRB requirements and approvals.
• Pre-screen and Screen subjects for eligibility using protocol specific inclusion and exclusion criteria.
• Entry of participant information and study visit procedures into the Clinical Trial Management System to ensure billing to appropriate funding sources.
• Maintains adequate inventory of study supplies. When handling investigational drugs/devices, follows the sponsor protocol and/or GI Alliance RESEARCH Policy on Investigational Drug/Device Accountability.
• Complete study documentation and maintenance of study files in accordance with sponsor requirements and GI Alliance RESEARCH policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
• Maintains effective and ongoing communication with sponsor, research participants, site manager, Regional Director, and PI during the course of the study.
• Manage the day to day activities of the study including problem solving, communication and protocol management.
• Collects and reports ongoing patient recruitment/ enrollment metrics to site manager and PI.
• Arranges secure storage of study documents that will be maintained according to Good Clinical Practice guidelines or for the contracted length of time, whichever is longer.
• Protects the rights and welfare of all human research participants involved in research in accordance with Federal regulations 
• Cooperates with GI Alliance RESEARCH compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office.
• Other duties as assigned.

Qualifications and experience

• RN license required  
• 1-3 years of Clinical Research Coordinating experience preferred 

Senior Clinical Research Coordinator

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

We are seeking a full-time, experienced Senior Clinical Research Coordinator (Sr. CRC). The Sr. CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.  

Responsibilities:

• Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication  and protocol management. 
• Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation to meet enrollment targets on assigned studies
• Schedule all patient research visits and procedures consistent with protocol requirements
• Conduct patient visits as outlined within each study protocol
• Dispense study medication, collect vital signs and perform ECGs
• Perform blood draws, process and ship specimens per study protocol and IATA regulations
• Ensure relevant study and subject specific information is entered into the CTMS system  on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms. 
• Act as point of contact for study participants
• Adhere to Research SOPs, Good Clinical Practices, and the study protocols
• Maintain ongoing communication with the CRO, sponsor, research participants, Site  Manager and PI throughout course of the study
• Ensure all safety data is reviewed by the PI in a timely manner
• Maintain inventory of study equipment and supplies onsite at all times
• Support other site staff with coaching on best practices for clinical trials processes, patient interactions, and project management
• Work closely with Principal Investigators and referring positions to build understanding and enthusiasm for research opportunities for patients
• Participate actively in communication of status and results to management; contribute and implement ideas to improve site performance 
• Assess problem situations to identify causes, gather and process relevant information,  generate possible solutions; make recommendations to management to resolve the situations
• Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol. Meet requirements for data query resolution times and quality
• Schedule and prepare for monitor visits
• Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance 
• Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy
• New bullet ?

Iterative Health Expectations

All employees are expected to:  

• Perform quality work within deadlines with or without direct supervision
• Interact professionally with other employees, customers and suppliers
• Work effectively as a team contributor on all assignments
• Work independently while understanding the necessity for communicating and  coordinating work efforts with other employees and organizations

Qualifications

• Medical Assistant, LPN, Associates or Bachelor’s degree in a clinical or scientific-related discipline preferred
• Minimum 3 years of clinical research experience
• Experience in phlebotomy preferred
• Strong written and verbal communication skils
• Ability to read, interpret, and apply clinic policies and research protocols
• Ability to use standard office software
• Must be able to lift up to 25 pounds

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Clinical Research Coordinator II - Nurse

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

We are seeking a full-time, experienced Clinical Research Coordinator - Level II (CRC II). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.  

Responsibilities:

• Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication  and protocol management. Able to manage an increased number of studies and/or more complex studies
• Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation to meet enrollment targets on assigned studies
• Schedule all patient research visits and procedures consistent with protocol requirements
• Conduct patient visits as outlined within each study protocol
• Dispense study medication, collect vital signs and perform ECGs
• Perform blood draws, process and ship specimens per study protocol and IATA regulations
• If assigned, place IVs, administer IV medication, and fluids according to protocol. Monitor patients’ IV medications and tubing. Give intramuscular and subcutaneous injections according to protocol. Monitor patients during infusion and discharge patients as policies indicate.
• Ensure relevant study and subject specific information is entered into the CTMS system on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms. 
• Act as point of contact for study participants
• Adhere to Research SOPs, Good Clinical Practices, and the study protocols
• Maintain ongoing communication with the CRO, sponsor, research participants, Site  Manager and PI throughout course of the study
• Ensure all safety data is reviewed by the PI in a timely manner
• Maintain inventory of study equipment and supplies onsite at all times
• Participate actively in communication of status and results to management; contribute and implement ideas to improve site performance 
• Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol. Meet requirements for data query resolution times and quality
• Schedule and prepare for monitor visits
• Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance 
• Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy

Iterative Health Expectations

All employees are expected to:  

• Perform quality work within deadlines with or without direct supervision
• Interact professionally with other employees, customers and suppliers
• Work effectively as a team contributor on all assignments
• Work independently while understanding the necessity for communicating and  coordinating work efforts with other employees and organizations

Qualifications

• Registered Nurse
• Solid nursing background, concentration, or willingness to obtain advanced knowledge in GI specialty
• Minimum 3 years of clinical research experience
• Ability to own issues and problem solve independently 
• Experience in phlebotomy preferred
• Strong written and verbal communication skils
• Ability to read, interpret, and apply clinic policies and research protocols
• Ability to use standard office software
• Must be able to lift up to 25 pounds

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Clinical Research Coordinator II

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

We are seeking a full-time, experienced Clinical Research Coordinator - Level II (CRC II). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.  

Responsibilities:

• Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication  and protocol management. Able to manage an increased number of studies and/or more complex studies
• Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation to meet enrollment targets on assigned studies
• Schedule all patient research visits and procedures consistent with protocol requirements
• Conduct patient visits as outlined within each study protocol
• Dispense study medication, collect vital signs and perform ECGs
• Perform blood draws, process and ship specimens per study protocol and IATA regulations
• Ensure relevant study and subject specific information is entered into the CTMS system on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms. 
• Act as point of contact for study participants
• Adhere to Research SOPs, Good Clinical Practices, and the study protocols
• Maintain ongoing communication with the CRO, sponsor, research participants, Site  Manager and PI throughout course of the study
• Ensure all safety data is reviewed by the PI in a timely manner
• Maintain inventory of study equipment and supplies onsite at all times
• Participate actively in communication of status and results to management; contribute and implement ideas to improve site performance 
• Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol. Meet requirements for data query resolution times and quality
• Schedule and prepare for monitor visits
• Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance 
• Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy
• Possible new bullet?

Iterative Health Expectations

All employees are expected to:  

• Perform quality work within deadlines with or without direct supervision
• Interact professionally with other employees, customers and suppliers
• Work effectively as a team contributor on all assignments
• Work independently while understanding the necessity for communicating and  coordinating work efforts with other employees and organizations

Qualifications

• Medical Assistant, LPN, Associates or Bachelor’s degree in a clinical or scientific-related discipline preferred
• Minimum 3 years of clinical research experience
• Ability to own issues and problem solve independently 
• Experience in phlebotomy preferred
• Strong written and verbal communication skils
• Ability to read, interpret, and apply clinic policies and research protocols
• Ability to use standard office software
• Must be able to lift up to 25 pounds

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Clinical Research Coordinator II

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

We are seeking a full-time, experienced Clinical Research Coordinator - Level II (CRC II). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.  

Responsibilities:

• Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication  and protocol management. 
• Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation to meet enrollment targets on assigned studies
• Schedule all patient research visits and procedures consistent with protocol requirements
• Conduct patient visits as outlined within each study protocol
• Dispense study medication, collect vital signs and perform ECGs
• Perform blood draws, process and ship specimens per study protocol and IATA regulations
• Ensure relevant study and subject specific information is entered into the CTMS system on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms. 
• Act as point of contact for study participants
• Adhere to Research SOPs, Good Clinical Practices, and the study protocols
• Maintain ongoing communication with the CRO, sponsor, research participants, Site  Manager and PI throughout course of the study
• Ensure all safety data is reviewed by the PI in a timely manner
• Maintain inventory of study equipment and supplies onsite at all times
• Participate actively in communication of status and results to management; contribute and implement ideas to improve site performance 
• Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol. Meet requirements for data query resolution times and quality
• Schedule and prepare for monitor visits
• Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance 
• Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy

Iterative Health Expectations

All employees are expected to:  

• Perform quality work within deadlines with or without direct supervision
• Interact professionally with other employees, customers and suppliers
• Work effectively as a team contributor on all assignments
• Work independently while understanding the necessity for communicating and  coordinating work efforts with other employees and organizations

Qualifications

• Medical Assistant, LPN, Associates or Bachelor’s degree in a clinical or scientific-related discipline preferred
• Minimum 3 years of clinical research experience
• Experience in phlebotomy preferred
• Strong written and verbal communication skils
• Ability to read, interpret, and apply clinic policies and research protocols
• Ability to use standard office software
• Must be able to lift up to 25 pounds

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Research Assistant

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

We are seeking a full-time, on-site Research Assistant (RA). The RA is a specialized research professional working with and under the direction of the Clinical Principal Investigator (PI) and site management. The primary responsibility of the RA is to assist the Clinical Research  Coordinators with conduct of research studies. The RA supports and facilitates the daily  clinical trial activities and plays a supportive role in the conduct of the study. 

Responsibilities

• Assists Study Team with communicating study requirements to all individuals involved in the study
• Works with the Study Team to develop and implement recruitment strategies in accordance with site policies and IRB requirements and approvals
• Assists Study Team with screening subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion
• Assists Study Team as requested to register participants in the Clinical Trial Management System to ensure billing of study procedures to appropriate funding source
• Maintains inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or site policies on Investigational Drug/Device Accountability
• Assists Study Team in completing study documentation and maintenance of study files in accordance with sponsor requirements and site policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms
• Aids the Study Team in maintaining effective and ongoing communication with sponsor, research participants, site management and PI during the course of the study
• Works with the Study Team to manage the day to day activities of the study including problem solving, communication and protocol management
• Collects and reports ongoing patient recruitment/ enrollment progress and metrics to site management and PI
• As directed, process and ship specimens per study protocol and IATA regulations
• Arranges secure storage of study documents that will be maintained according to Good Clinical Practice guidelines or for the contracted length of time, whichever is longer
• Enter all patient visit data in e-CRF and CTMS on a daily basis or as directed
• Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance 
• Other duties as assigned

Iterative Health Expectations

All employees are expected to:  

• Perform quality work within deadlines with or without direct supervision
• Interact professionally with other employees, customers and suppliers
• Work effectively as a team contributor on all assignments
• Work independently while understanding the necessity for communicating and  coordinating work efforts with other employees and organizations

Qualifications

• High school diploma or equivalent. Some college preferred
• Minimum 2 years in a healthcare setting
• Strong written and verbal communication skils
• Ability to read, interpret, and apply clinic policies and research protocols
• Ability to use standard office software
• Must be able to lift up to 25 pounds

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Clinical Research Coordinator I - Nurse

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

We are seeking a full-time, experienced Clinical Research Coordinator (CRC). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.  

Responsibilities:

• Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication  and protocol management. 
• Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation
• Schedule all patient research visits and procedures consistent with protocol requirements
• Conduct patient visits as outlined within each study protocol
• Dispense study medication, collect vital signs and perform ECGs
• Perform blood draws, process and ship specimens per study protocol and IATA regulations
• If assigned, place IVs, administer IV medication, and fluids according to protocol. Monitor patients’ IV medications and tubing. Give intramuscular and subcutaneous injections according to protocol. Monitor patients during infusion and discharge patients as policies indicate.
• Ensure relevant study and subject specific information is entered into the CTMS system  on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms. 
• Act as point of contact for study participants
• Adhere to Research SOPs, Good Clinical Practices, and the study protocols
• Maintain ongoing communication with the CRO, sponsor, research participants, Site  Manager and PI throughout course of the study
• Ensure all safety data is reviewed by the PI in a timely manner 
• Maintain inventory of study equipment and supplies onsite at all times
• Participate actively in communication of status and results to management 
• Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol
• Schedule and prepare for monitor visits
• Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance 
• Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy

Iterative Health Expectations

All employees are expected to:  

• Perform quality work within deadlines with or without direct supervision
• Interact professionally with other employees, customers and suppliers
• Work effectively as a team contributor on all assignments
• Work independently while understanding the necessity for communicating and  coordinating work efforts with other employees and organizations

We are seeking a full-time, experienced Clinical Research Coordinator (CRC). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.  

Responsibilities:

• Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication  and protocol management. 
• Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation
• Schedule all patient research visits and procedures consistent with protocol requirements
• Conduct patient visits as outlined within each study protocol
• Dispense study medication, collect vital signs and perform ECGs
• Perform blood draws, process and ship specimens per study protocol and IATA regulations
• Ensure relevant study and subject specific information is entered into the CTMS system  on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms. 
• Act as point of contact for study participants
• Adhere to Research SOPs, Good Clinical Practices, and the study protocols
• Maintain ongoing communication with the CRO, sponsor, research participants, Site  Manager and PI throughout course of the study
• Ensure all safety data is reviewed by the PI in a timely manner 
• Maintain inventory of study equipment and supplies onsite at all times
• Participate actively in communication of status and results to management 
• Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol
• Schedule and prepare for monitor visits
• Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance 
• Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy

Iterative Health Expectations

All employees are expected to:  

• Perform quality work within deadlines with or without direct supervision
• Interact professionally with other employees, customers and suppliers
• Work effectively as a team contributor on all assignments
• Work independently while understanding the necessity for communicating and  coordinating work efforts with other employees and organizations

Qualifications

• Medical Assistant, LPN, Associates or Bachelor’s degree in a clinical or scientific-related discipline preferred
• Minimum 1-2 years of clinical research experience
• Able to execute on research tasks with guidance from more experienced staff, PIs, and management
• Strong written and verbal communication skils
• Ability to read, interpret, and apply clinic policies and research protocols
• Ability to use standard office software
• Must be able to lift up to 25 pounds

Clinical Research Coordinator II

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

We are seeking a full-time, experienced Clinical Research Coordinator - Level II (CRC II). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.  

Responsibilities:

• Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication  and protocol management. 
• Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation to meet enrollment targets on assigned studies
• Schedule all patient research visits and procedures consistent with protocol requirements
• Conduct patient visits as outlined within each study protocol
• Dispense study medication, collect vital signs and perform ECGs
• Perform blood draws, process and ship specimens per study protocol and IATA regulations
• Ensure relevant study and subject specific information is entered into the CTMS system on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms. 
• Act as point of contact for study participants
• Adhere to Research SOPs, Good Clinical Practices, and the study protocols
• Maintain ongoing communication with the CRO, sponsor, research participants, Site  Manager and PI throughout course of the study
• Ensure all safety data is reviewed by the PI in a timely manner
• Maintain inventory of study equipment and supplies onsite at all times
• Participate actively in communication of status and results to management; contribute and implement ideas to improve site performance 
• Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol. Meet requirements for data query resolution times and quality
• Schedule and prepare for monitor visits
• Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance 
• Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy

Iterative Health Expectations

All employees are expected to:  

• Perform quality work within deadlines with or without direct supervision
• Interact professionally with other employees, customers and suppliers
• Work effectively as a team contributor on all assignments
• Work independently while understanding the necessity for communicating and  coordinating work efforts with other employees and organizations

Qualifications

• Medical Assistant, LPN, Associates or Bachelor’s degree in a clinical or scientific-related discipline preferred
• Minimum 3 years of clinical research experience
• Experience in phlebotomy preferred
• Strong written and verbal communication skils
• Ability to read, interpret, and apply clinic policies and research protocols
• Ability to use standard office software
• Must be able to lift up to 25 pounds

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.