Clinical Research Monitor
About The Position
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. Job Summary Conduct site monitoring visits in accordance with standards of practice guidelines and federal regulations to ensure that the rights and well-being of human subjects are protected and electronic case report forms (e-CRF) are accurate, complete, and verifiable from source documents.
Requirements
- Bachelor's Degree required; experience can be considered in lieu of a degree
- At least 1-2 years of clinical research experience required
- Ability to work independently and as a team member.
- Strong attention to detail and organizational skills.
- Knowledge of clinical research protocols.
- Knowledge of data management programs.
- Computer literacy.
- Knowledge of clinical trials, research, and general medicine.
Nice To Haves
- Previous experience with monitoring highly preferred
Responsibilities
- Responsible for conducting study monitoring visits to assess protocol and regulatory compliance per the approved monitoring plan.
- Review and compare source documentation to CRFs to ensure data is complete and accurate.
- Draft site monitoring plans
- Provide Investigator and study staff training at study initiation and as needed through the course of the trial
- Review study-specific site documents, including regulatory documents, drug and device accountability logs, training logs, and delegation of authority logs.
- Maintain regular communication with assigned sites to support site enrollment, data entry, query resolution, and patient retention.
- Document site visit findings and observations via trip reports and letters.
- Escalate major visit findings as described in the monitoring plan to appropriate study team members.
- Prepare trip reports and follow-up letters; track issues to closure via CAPA where needed
- Participate in weekly meetings with the study team.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
