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 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