Clinical Research Associate/Coordinator I

Mass General Brigham • Boston, MA

6d • $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 position includes training in institutional and federal clinical research regulations and combines data abstraction and entry, regulatory management, and patient coordination, with direct patient contact. All duties are performed under the general supervision of the Clinical Research Manager.

Requirements

• Bachelor's degree required; experience cannot be substituted for the degree.
• 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

• One to two years of clinical research or compliance experience preferred.

Responsibilities

• Assist the clinical team in screening potential patients for study participation.
• Schedule protocol-required tests, procedures, appointments, and clinical safety laboratory specimen draws; coordinate appointments with physicians, nurses, and test areas and ensure timely laboratory 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 answer frontline 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 required tissue samples and coordinate the collection and processing of correlative research blood samples with the MGH Sample Processing Lab.
• Obtain vital signs, perform EKGs, and administer quality-of-life assessments when required by study protocols.
• Verify documentation of consent, screening tests and procedures, and eligibility criteria to ensure patients meet inclusion and exclusion requirements.
• Enroll patients as required by study sponsors and the internal enrollment monitor team.
• Follow patients throughout 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 or electronic files and ensure adequate source documentation for reported data.
• Resolve sponsor data queries and obtain protocol clarifications from sponsors, communicating relevant information to the research team.
• Schedule and prepare for sponsor monitoring visits, participate in monitoring visits, and file related correspondence.
• Facilitate requests and shipment of archival pathology samples.
• Organize and prepare for internal and external audits.
• Maintain ongoing communication with the clinical team about study patients and progress across multiple studies.
• Maintain and organize study-specific regulatory binders.
• Prepare and submit protocol amendments, continuing reviews, safety reports, and Data and Safety Monitoring Reports to the appropriate entities.
• Revise informed consent documents to reflect new risk information or updated protocol requirements.
• Manage adverse-event and deviation, violation, or exception documentation and report it to sponsors and the IRB as required.
• Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout clinical trials.
• Collect, complete, and submit essential regulatory documents to regulatory entities.
• Ensure appropriate documentation of delegation and training for study staff and maintain screening and enrollment logs.

Benefits

• 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