Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Precision for Medicine is looking for a Senior/Clinical Research Associate. 

Position Summary:

The CRA provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The CRA is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.

Essentials functions of the job included but not limited to:

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
• Minimum of 2 years of on-site monitoring experience for CRAII; 1 year oncology and Phase I experience preferred

Other required:

• High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanour; demonstrate flexibility and teamwork.
• Ability to focus on detail for extended periods of time, high attention to accuracy.
• Fluency in English communication, verbally and in writing.
• Working knowledge of the drug development process.
• Travelling required (60-70%)

Preferred:

• Solid experience in clinical research or related experience.
• Excellent organizational skills.
• Ability to work efficiently in a remote work environment.

Competencies:

• Good knowledge and utilization of ICH-GCP, Precision SOPs, and regulatory guidance.
• Demonstrates solid interpersonal skills.
• Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment.
• Good written and verbal communication skills and presentation skills.
• Ability to deliver on commitments.
• Commitment to performing professionally consistent with Precision Principles.

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Position Summary:

The Senior/Project Manager plans, directs, coordinates, and delivers activities for designated clinical-study projects to ensure that project objectives of quality, scope, cost, and time are accomplished.

PM will either manage regional trials (moderate complexity) and/or supportive role in managing complex global trials. The essential functions below will describe the PM acting in a primary / lead PM role on a study. When in a supportive role on a global study, the essential functions will be delegated by the Global Lead.

Essential functions of the job include but are not limited to:
• Serve as primary point-of-contact and primary escalation point to the client
• Coordinate and oversees all functional services including external vendors to the established timeline and budget
• Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate. • Ensure functional areas are fully aware of the study scope and are managing the scope for their functional areas accordingly.
• Manage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on time, accurate billing and forecasting to support business objectives.
• Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality
• Ensure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings.
• Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation
• Establish tracking metrics to monitor trial and team progress towards project goals
• Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise
• Lead both internal and client meetings and set expectations for the project team
• Communicate effectively with client and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues
• Ensure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the project
• Support business development and marketing activities as appropriate, including travel to Bid Defence meetings as required
• Perform other duties as assigned by management
• Remain compliant with organisational training, time-reporting and any other administrative duties as required
• Provides on-going feedback for functional team members including annual performance reviews
• Ability to travel domestically and internationally including overnight stays

Qualifications:
Minimum Required:
• Degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred
• Minimum of 4-7 years of clinical research experience or proven competencies for this position and a minimum of 2-4 years of leading a project
• Experience managing regional trials (moderate complexity) and/or supportive role in managing complex global trials

Other Required:
• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint), Microsoft Project,eTMF, EDC and CTMS
• Good communication and interpersonal skills to effectively interface with others in a team setting
• Good organizational skills, attention to detail, and a customer service demeanor

• Mandarin Speaking as this is required to cover East Asia market

Competencies:
• Demonstrates knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability to implement such items
• Working knowledge of project management techniques and tools
• Experience working in a cross-functional project management environment
• Fundamental understanding of cross-functional management
• Fundamental understanding of project planning, risk management and change management with an awareness of appropriate escalation
• High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective
• Ability to lead and inspire excellence within a study team
• Ability to create an environment where study team members have a sense of ownership that will lead to increases in productivity and efficiency
• Results oriented, accountable, motivated and flexible
• Good time management, negotiation, critical thinking, decision making, analytical and interpersonal skills
• Good presentation, verbal and written communications skills
• Fundamental understanding of project management software
• Experience in pharmaceutical and/or device research required

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues to grow we are seeking a Regulatory and Start Up Specialist to join our growing team.

Essential functions of the job include but are not limited to:

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.

• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team 
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication and secure site 
• review and manage collection of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Form. 
• Responsible for/facilitates the translation and co-ordination of translations for documents.
• Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF
• May support the clinical team performing Pre-Study Site Visits.

The ideal candidate will have:

Minimum Required:

• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. 
• A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial.
• 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.

Other Required:

• Strong communication and organizational skills. 
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English. 

Preferred:

• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience. 
• Experience using milestone tracking tools/systems.
• Ability to prioritize workload to meet deadlines
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science.

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues to grow we are seeking a Site Start Up Lead APAC to join our growing team. Location : Based in Australia/Singapore/South Korea/Taiwan/China.

Position Summary:
The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

Essential functions of the job include but are not limited to:
• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
• Responsible to co-ordinate translations for documents required for submissions.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
• If needed, directly support country or site level activities start up activities.
• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
• Interact with clients in proposal activities, including slide development and client presentation as required.

Qualifications:
Minimum Required:
• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.

Other Required:
• Demonstrated leadership experience in driving cross-functional activities
• Excellent communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
• Experience using milestone tracking tools/systems

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues to grow we are seeking a Site Start Up Lead APAC to join our growing team. Location : Based in Australia/Singapore/South Korea/Taiwan/China.

Position Summary:
The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

Essential functions of the job include but are not limited to:
• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
• Responsible to co-ordinate translations for documents required for submissions.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
• If needed, directly support country or site level activities start up activities.
• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
• Interact with clients in proposal activities, including slide development and client presentation as required.

Qualifications:
Minimum Required:
• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.

Other Required:
• Demonstrated leadership experience in driving cross-functional activities
• Excellent communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
• Experience using milestone tracking tools/systems

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues to grow we are seeking a Site Start Up Lead APAC to join our growing team. Location : Based in Australia/Singapore/South Korea/Taiwan/China.

Position Summary:
The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

Essential functions of the job include but are not limited to:
• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
• Responsible to co-ordinate translations for documents required for submissions.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
• If needed, directly support country or site level activities start up activities.
• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
• Interact with clients in proposal activities, including slide development and client presentation as required.

Qualifications:
Minimum Required:
• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.

Other Required:
• Demonstrated leadership experience in driving cross-functional activities
• Excellent communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
• Experience using milestone tracking tools/systems

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues to grow we are seeking a Site Start Up Lead APAC to join our growing team. Location : Based in Australia/Singapore/South Korea/Taiwan/China.

Position Summary:
The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

Essential functions of the job include but are not limited to:
• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
• Responsible to co-ordinate translations for documents required for submissions.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
• If needed, directly support country or site level activities start up activities.
• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
• Interact with clients in proposal activities, including slide development and client presentation as required.

Qualifications:
Minimum Required:
• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.

Other Required:
• Demonstrated leadership experience in driving cross-functional activities
• Excellent communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
• Experience using milestone tracking tools/systems

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Precision for Medicine is looking for an CRA II (based in Shanghai and Beijing or Taiwan)

Position Summary:

The CRA II provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The CRA is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.

Essentials functions of the job included but not limited to:

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
• Minimum of 2 years of on-site monitoring experience; 1 year oncology experience； 
• Global Clinical Trial experience

Other required:

• High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanour; demonstrate flexibility and teamwork.
• Ability to focus on detail for extended periods of time, high attention to accuracy.
• Fluency in English communication, verbally and in writing.
• Working knowledge of the drug development process.
• Travelling required (60-70%)

Preferred:

• Solid experience in clinical research or related experience.
• Excellent organizational skills.
• Ability to work efficiently in a remote work environment.

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues to grow we are seeking a Site Start Up Lead APAC to join our growing team. Location : Based in Australia/Singapore/South Korea/Taiwan/China.

Position Summary:
The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

Essential functions of the job include but are not limited to:
• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
• Responsible to co-ordinate translations for documents required for submissions.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
• If needed, directly support country or site level activities start up activities.
• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
• Interact with clients in proposal activities, including slide development and client presentation as required.

Qualifications:
Minimum Required:
• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.

Other Required:
• Demonstrated leadership experience in driving cross-functional activities
• Excellent communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
• Experience using milestone tracking tools/systems

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

We are hiring for Project Support Specialist.

The Project Support Specialist serves as a member of the project team providing cross-functional support with the goal of contributing toward efficient management of the studies to which they are assigned. The PSS is a solid team member who can execute, with some oversight, all core responsibilities consistently across several studies using independent judgment and critical thinking. The PSS effectively collaborates with their cross-functional team members and will take on new or expanded responsibilities when appropriate and with proper training. The PSS II prioritizes their work and collaborates with the project team to ensure a consistent understanding of the timing for completion of work products.

Essential functions of the job include but are not limited to:

• Manages the meeting lifecycle including scheduling internal and external meetings, preparing, and circulating agendas, taking meeting minutes, circulating, and updating meeting minutes based on team member input, and filing meeting agendas and minutes in the Trial Master File.
• Assists with creation and maintenance of the project timeline in MS Project or similar system. Collects updates from team members, captures and documents these updates, and ensures updates are communicated to the cross-functional study team.
• Performs an array of activities and tasks in clinical systems applicable to their role and project scope.
• Manages study-specific training lifecycle by collecting, tracking, and loading training materials, assigning team members to appropriate training, and documenting completion of study-specific training in appropriate systems. Manages the maintenance of training records and files records in the Trial Master File.
• Identifies gaps in training by reviewing team member training compliance on a defined periodic basis and engages appropriate team members to ensure training completeness. Escalates to the Project Manager as needed.
• Establishes a study-level Share Point site or similar shared working space and ensures appropriate access to study team, sponsors, and others as appropriate.
• Creates project-specific email boxes and maintains appropriate access to study team members.
• Manages user access to study systems by submitting user requests to the Helpdesk or similar, by reviewing team member access on a defined periodic basis, and documenting access reviews. Ensure rapid removal of system access for team members no longer affiliated with the study.
• Orders study supplies and addresses queries on study supplies.
• Prepares study binder materials and works with vendor to ensure proper binder creation and shipping to study sites. Works with vendor to obtain project-related cost estimates. Ensures vendor quotes align with invoices for completed binders and consults directly with Project Manager to approve vendor payments.
• Maintains various study trackers as needed and directed by the Project Manager, Clinical Trial Manager, or other project leader.
• Manages the addition and removal of project team members in the finance system, including assignment of team members to specific tasks for time tracking.
• Reviews and approves weekly time reporting by team members. Identifies and escalates time reporting concerns to the Project Manager.
• With oversight by the Safety Lead, supports the distribution and tracking of IND Safety Reports/SUSARS/CIOMS according to the procedures defined by the study team in the project plan, as applicable.
• Manages the translation of site level documents, as applicable, per local and regional standards through document collection, tracking, vendor collaboration, engagement of stakeholders to evaluate translation completeness and vendor payments.
• Supports the management of project-specific vendors by assisting with development of the Vendor Management Plan, providing vendors with project trainings and access to systems, tracking vendor issues and overseeing vendor invoicing and payments.
• Manages the preparation, distribution, and the reconciliation of study material during applicable phases of the study (Operations Manual, ISF, patient cards, etc.) as applicable.
• Supports the Project Manager with the production of various study plans, reports and updates (e.g., PM plan, country/site initiation, activation, recruitment) including preparing initial drafts, managing the collection of team member input, and finalizing content.
• Collects data and maintains monthly Key Performance Indicators (KPIs) and project health data. Circulates data to the Project Manager and internal team members as appropriate.
• Collects functional team input for the quarterly inspection readiness review.
• May support team leaders with the production of various study reports and updates (e.g., country/site initiation, activation, recruitment).
• Supports the Project Manager in the creation and maintenance of the Sponsor-facing study story board.
• Supports the Project Manager in tracking out of scope work. Prepares, with guidance, materials required for the submission of change orders.
• Performs other duties as assigned by the Project Manager.

Qualifications:

Minimum Required:

• 4-year college degree or international equivalent; or equivalent experience ideally in a business, scientific or healthcare discipline
• Minimum 2 years relevant experience or demonstrated competencies in the key requirements of the role.

Other Required:

• Fluency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanor; demonstrate flexibility, teamwork, and a keen attention to detail.
• Ability to communicate both verbally and in writing at the English proficiently.

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences.

As our organisation continues to grow we are delighted to be expanding our business in Asia Pacific and are now looking for a Senior Clinical Data Manager.

Position Summary:
The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.

Essential functions of the job include but are not limited to:
• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• May perform quality control of data entry
• Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
• Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
• May assist in building clinical databases
• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
• May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
• Review and query clinical trial data according to the Data Management Plan
• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
• Run patient and study level status and metric reporting
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
• Coordinate SAE/AE reconciliation
• Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
• May assist with SAS programming and quality control of SAS programs used in the Data Management department
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
• May review Request for Proposals (RFP), proposals, provide project estimates
• Provide leadership for cross-functional and organization-wide initiatives, where applicable
• Trains and ensures that all data management project team members have been sufficiently trained
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
• May present software demonstrations/trainings, department/company training sessions, present at project meetings
• May require some travel
• Perform other duties as assigned

Requirement :
• Bachelors and/or a combination of related experience
• 8+ years’ experience
• Able to handle a variety of clinical research tasks
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral
• Experience in utilizing various clinical database management systems
• Broad knowledge of drug, device and/or biologic development and effective data management practices
• Strong representational skills, ability to communicate effectively orally and in writing
• Strong leadership and interpersonal skills

• Systems knowledge with Medidata Rave and Veeva
• Ability to undertake occasional travel

Preferred:

• Experience in a clinical, scientific or healthcare discipline
• Dictionary medical coding (MedDRA and WHODrug)
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)
• Oncology and/or Orphan Drug therapeutic experience
• Knowledge of Biostatistics

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences.

As our organisation continues to grow we are delighted to be expanding our business in Asia Pacific and are now looking for a Senior Clinical Data Manager.

Position Summary:
The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.

Essential functions of the job include but are not limited to:
• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• May perform quality control of data entry
• Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
• Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
• May assist in building clinical databases
• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
• May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
• Review and query clinical trial data according to the Data Management Plan
• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
• Run patient and study level status and metric reporting
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
• Coordinate SAE/AE reconciliation
• Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
• May assist with SAS programming and quality control of SAS programs used in the Data Management department
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
• May review Request for Proposals (RFP), proposals, provide project estimates
• Provide leadership for cross-functional and organization-wide initiatives, where applicable
• Trains and ensures that all data management project team members have been sufficiently trained
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
• May present software demonstrations/trainings, department/company training sessions, present at project meetings
• May require some travel
• Perform other duties as assigned

Requirement :
• Bachelors and/or a combination of related experience
• 8+ years’ experience
• Able to handle a variety of clinical research tasks
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral
• Experience in utilizing various clinical database management systems
• Broad knowledge of drug, device and/or biologic development and effective data management practices
• Strong representational skills, ability to communicate effectively orally and in writing
• Strong leadership and interpersonal skills

• Systems knowledge with Medidata Rave and Veeva
• Ability to undertake occasional travel

Preferred:

• Experience in a clinical, scientific or healthcare discipline
• Dictionary medical coding (MedDRA and WHODrug)
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)
• Oncology and/or Orphan Drug therapeutic experience
• Knowledge of Biostatistics

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Precision for Medicine is looking for an Senior / CRA  (based in HongKong)

Position Summary:

The CRA  provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The CRA is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.

Essentials functions of the job included but not limited to:

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
• Minimum of 2 years of on-site monitoring experience; 1 year oncology experience； 
• Global Clinical Trial experience

Other required:

• High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanour; demonstrate flexibility and teamwork.
• Ability to focus on detail for extended periods of time, high attention to accuracy.
• Fluency in English communication, verbally and in writing.
• Working knowledge of the drug development process.
• Travelling required (60-70%)

Preferred:

• Solid experience in clinical research or related experience.
• Excellent organizational skills.
• Ability to work efficiently in a remote work environment.