Clinical Research Associate/Coordinator I

Mass General Brigham•Boston, MA

19h•Hybrid

About The Position

The General Hospital Corporation Mass General Brigham is a not-for-profit organization that supports patient care, research, teaching, and community service, striving to provide exceptional care and drive groundbreaking medical discoveries. The Clinical Research Associate/Clinical Research Coordinator I (CRA/CRC I) works under general supervision to enroll eligible patients in clinical research protocols and manage all aspects of data collection and submission for multiple cancer studies. This role acts as a liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting, while also ensuring compliance with institutional and federal regulations governing clinical research. The position involves a combination of data abstraction and entry, regulatory management, and patient coordination, including direct patient contact.

Requirements

Bachelor's Degree
Ability to work independently and as a team member
Analytical skills and ability to resolve problems
Ability to interpret acceptability of data results
Careful attention to detail
Good organizational and communication skills
Working knowledge of clinical research protocols

Nice To Haves

1-2 years of Clinical Research or compliance experience

Responsibilities

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 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 correspondence
Ensure appropriate documentation of delegation and training for all study staff members
Maintain screening and enrollment logs