Job Title: Medical Monitors - 3 openings

Work Location: Suffolk County, Massachusetts

Summary:

This position involves serving as a medical monitor (CRA) for clinical research studies, focusing on ensuring protocol and regulatory compliance, data accuracy, and subject safety. The role is part of a growing team and offers a long-term contract opportunity.

Responsibilities:

• Conduct remote and onsite monitoring visits to assess compliance with study protocols and regulatory requirements.
• Review and compare source documentation with electronic case report forms (e-CRFs) to ensure data accuracy and completeness.
• Draft and implement site monitoring plans tailored to each clinical study.
• Provide training to investigators and study staff at study initiation and throughout the trial as needed.
• Review and maintain study-specific site documents, including regulatory files, accountability logs, and training records.
• Maintain regular communication with assigned sites to support enrollment, data entry, query resolution, and patient retention.
• Document findings from site visits through trip reports and follow-up letters, escalating major issues as necessary.
• Participate in weekly study team meetings and track issue resolution through CAPA processes when required.

Qualifications:

• Bachelor's degree required; relevant experience may be considered in lieu of a degree.
• At least 1-2 years of clinical research experience required.
• Previous experience with monitoring highly preferred.
• Ability to work independently and collaboratively within a team.
• Strong attention to detail and organizational skills.
• Knowledge of clinical research protocols and data management programs.
• Computer literacy and familiarity with clinical trials and general medicine.
• Psychiatry experience preferred but not required.

Published Category: Clinical Operations & Development