Clinical Research Associate​/Coordinator

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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.

• 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

• 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

• Maintain and organize study specific regulatory binders
• Prepare and submit protocol amendments, continuing reviews, and safety reports…