Clinical Research Associate​/Clinical Research Coordinator

Mass General Brigham is a not‑for‑profit health system that supports patient care, research, teaching, and community service. Our goal is to provide exceptional care and to advance medical discoveries through high‑performing teams. We invite professionals—including doctors, nurses, business people, tech experts, researchers, and systems analysts—to join us and experience the impact of translational research.

Works independently under general supervision to enroll eligible patients in translational clinical research protocols and manage all aspects of data collection and submission for multiple cancer studies. The Clinical Research Associate/Coordinator is the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication, regulatory compliance, and timely reporting.

• Interface professionally with physicians, research nurses, pathologists, and patients to support translational research projects.
• Coordinate the collection, processing, and shipping of tissue and blood samples, including spin/separation/freeze protocols with the MGH Sample Processing Lab (SPL).
• Obtain informed consent and explain study protocols to patients for minimal‑risk specimen collection studies.
• Screen and follow patients for specific projects, assist in screening potential participants, and schedule all protocol‑required tests and procedures.
• Maintain point‑of‑contact communication with enrolled patients, handling front‑line questions and ensuring timely results for providers.
• Develop protocol‑specific flow charts, intake sheets, and other tools to ensure compliance and proper data acquisition.
• Collect detailed clinical and treatment information on patients undergoing genetic testing or cancer treatments and maintain an updated database.
• Verify documentation of consent, screening tests, and eligibility criteria to ensure patients meet inclusion/exclusion criteria.
• Enroll patients as required by study sponsors and the internal monitoring team.
• Follow patients for the duration of the study via electronic medical record review to ensure protocol compliance.
• Complete data entry for individual study protocols, ensuring compliance with institutional and regulatory requirements.
• Maintain research charts and/or electronic files for all enrolled patients, resolving data queries and obtaining protocol clarifications.
• Manage adverse event and deviation documentation, reporting to sponsors and the IRB as required.
• Collect, complete, and submit essential regulatory documents to various regulatory entities, including IRB amendments, continuing reviews, and safety reports.
• Maintain study‑specific regulatory binders, and ensure training documentation for all study staff.
• Prepare monthly enrollment and data summaries for the study team, and assist in abstracts, presentations, and manuscripts.
• Collaborate with the clinical team on study patient updates and progress for multiple studies.
• Participate in new study submissions and updates to current studies.

• Education: Bachelor’s Degree in a related field (experience in lieu of a degree not accepted).
• Licenses & Credentials: None required.
• Experience: 1‑2 years of clinical research or compliance experience preferred.
• Knowledge, Skills, and Abilities:
  • Ability to work independently and as part of a team.
  • Analytical skills and problem‑solving ability.
  • Interpretation of data results and careful attention to detail.
  • Strong organizational and communication skills.
  • Working knowledge of clinical research protocols.
  • Good interpersonal skills and professional demeanor.

• Standing:
  Frequently (34‑66%)
• Walking:
  Frequently (34‑66%)
• Sitting:
  Occasionally (3‑33%)
• Lifting 35 lbs+ with assisted device:
  Frequently (34‑66%)
• Carrying 20‑35 lbs:
  Frequently (34‑66%)
• Pushing/Pulling:
  Occasionally (3‑33%)
• Balancing:
  Frequently (34‑66%)
• Other tasks:
  Climbing Rarely, Stooping Occasionally, Kneeling Occasionally, Crouching Occasionally, Crawling Rarely, Reaching Frequently, Gross Manipulation Frequently, Fine Manipulation Frequently, Feeling Constantly, Foot Use Rarely, Vision – Far Constantly, Vision – Near Constantly, Talking Constantly,…