Clinical Research Associate/Coordinator I

Mass General Brigham • Boston, MA

1d • $20 - $29 • Onsite

About The Position

The Clinical Research Associate/Clinical Research Coordinator I works under general supervision to enroll eligible patients in clinical research protocols and manage data collection and submission for multiple cancer studies. The role serves as a liaison among the clinical team, study sponsors, and the Institutional Review Board (IRB), supporting appropriate communication and reporting. The coordinator receives training on institutional and federal clinical research regulations. The position combines data abstraction and entry, regulatory management, and patient coordination, and involves direct patient contact.

Under the general supervision of the Clinical Research Manager, the role supports study screening and enrollment, coordinates protocol-required appointments, tests, procedures, and specimens, and maintains communication with patients and the clinical team. It also performs data management and may perform regulatory duties, including maintaining study records, preparing submissions, and supporting monitoring visits and audits.

Requirements

• Bachelor's degree required.
• Ability to work independently and as a team member.
• Analytical skills and ability to resolve problems.
• Ability to interpret the 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 preferred.

Responsibilities

• Assist the clinical team in screening potential patients for study participation.
• Schedule protocol-required tests and procedures and coordinate patient appointments with physicians, nurses, and testing areas.
• Coordinate clinical safety laboratory specimen draws and ensure timely results are available to providers.
• Prepare pre-visit communications to help providers complete and document required assessments.
• Maintain point-of-contact communication with enrolled patients and assist with questions about study participation.
• Develop protocol-specific flow charts, intake sheets, and other tools to support protocol compliance and data acquisition.
• Coordinate, obtain, process, and ship protocol-required tissue samples.
• Coordinate with the MGH Sample Processing Lab to ensure collection and processing of required correlative research blood samples, including spinning, separating, and freezing samples.
• Obtain vital signs and perform EKGs when required by individual studies.
• Administer quality-of-life assessments when required by individual studies.
• Verify documentation of consent, screening tests and procedures, and eligibility criteria to confirm patients meet inclusion and exclusion criteria.
• Enroll patients as required by study sponsors and the internal enrollment monitor team.
• Follow patients during study participation through electronic medical record review to ensure protocol compliance.
• Enter study data in accordance with protocol, institutional, and regulatory requirements.
• Monitor and report adverse events and deviations as required by sponsors, the institution, and federal regulations.
• Maintain research charts and/or electronic files for enrolled patients and ensure adequate source documentation for reported data.
• Resolve data queries issued by study sponsors.
• Obtain protocol clarifications from sponsors and communicate them to the research team.
• Schedule and prepare for sponsor monitoring visits.
• Facilitate requests for and shipment of archival pathology samples.
• Organize and prepare for internal and external audits.
• Maintain ongoing communication with the clinical team regarding study patients and progress across multiple studies.
• Maintain and organize study-specific regulatory binders, as applicable.
• Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB, as applicable.
• Revise informed consent documents to incorporate new risk information and updated protocol requirements, as applicable.
• Manage adverse-event and deviation, violation, or exception documentation and report it to sponsors and the IRB as required.
• Submit Data and Safety Monitoring Reports, as applicable.
• Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process.
• Collect, complete, and submit essential regulatory documents to regulatory entities, as applicable.
• Participate in monitoring visits and file monitoring-visit correspondence, as applicable.
• Ensure appropriate documentation of delegation and training for study staff, as applicable.
• Maintain screening and enrollment logs, as applicable.

Benefits

• Competitive base pay.
• Comprehensive benefits.
• Career advancement opportunities.
• Differentials, premiums, and bonuses as applicable.
• Recognition programs designed to celebrate contributions and support professional growth.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level