Clinical Research Monitor

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. Essential Functions -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.

Education

• Bachelor's Degree required; experience can be considered in lieu of a degree

Experience

• At least 1-2 years of clinical research experience required
• Previous experience with monitoring highly preferred

Knowledge, Skills, and Abilities

• 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.

Working Conditions

• This is a hybrid role that requires an onsite presence at the office (325 Cambridge Street in Boston) 3x/week

Mass General Brigham Incorporated is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.