Clinical Research Associate/Coordinator I

Site: The General Hospital Corporation

 

Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

 

The Clinical Research Associate/Clinical Research Coordinator I (CRA/CRC I) works under general supervision to enroll eligible patients to clinical research protocols and manage all aspects of data collection and submission for multiple cancer studies. The CRA/CRC I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. The CRA/CRC I will be trained on the institutional and federal regulations governing clinical research. The position involves a combination of data abstraction and entry, regulatory management, and patient coordination. The position involves direct patient contact.


Principal Duties and Responsibilities:


All duties will be performed under general supervision by the Clinical Research Manager.


The following clinical duties will be performed:

· Assist clinical team in screening potential patients for study participation

· Schedule all protocol required tests and procedures

· Coordinate patient appointments with physicians, nurses, and all test areas

· Coordinate and schedule clinical safety laboratory specimen draws and ensure timely results are available to providers

· Prepare pre-visit communication for providers to ensure required assessments are completed and documented

· Maintain point of contact communication with enrolled patients and assist with front line questions regarding study participation

· Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition

· Coordinate, obtain, process, and ship protocol required tissue samples

· Ensure collection and processing (e.g. spin/separate/freeze) of all required correlative research blood samples with the coordination of the MGH Sample Processing Lab (SPL)

· Obtain vital signs and perform EKGs as required for individual studies

· Administer quality of life assessments as required for individual studies


The following data management responsibilities will be performed:


· Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria

· Enroll patients as required by the study sponsor and internal enrollment monitor team

· Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance

· Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements.

· Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations

· Maintain research charts and/or electronic files for all enrolled patients

· Ensure adequate source documentation is in place for all data reported

· Resolve data queries issued by the sponsor

· Obtain protocol clarifications from the study sponsor and communicate information to the research team

· Schedule and prepare for monitoring visits with sponsors

· Facilitate the request and shipment of archival pathology samples

· Organize and prepare for internal and external audits

· Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies


The following regulatory duties may be performed:

· Maintain and organize study specific regulatory binders

· Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB

· Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study

· Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required

· Submit Data and Safety Monitoring Reports

· Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process

· Collect, complete, and submit essential regulatory documents to various regulatory entities

· Participate in monitoring visits and file all monitoring visit