Clinical Research Monitor at Partner's Healthcare in Boston, Massachusetts at Disabledperson, Inc

Job Title

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.

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.

Qualifications:

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

Additional Job Details (if applicable):

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

Remote Type: Hybrid Work Location: 325 Cambridge Street Scheduled Weekly Hours: 40 Employee Type: Regular Work Shift: Day (United States of America) Pay Range: $50,502.40 - $82,014.40/Annual Grade 6