Senior Clinical Research Associate

The Senior Clinical Research Associate is a key contributor to Clinical Operations, providing senior-level co-monitoring and quality oversight to support the successful execution of clinical trials. This individual partners with CRAs, CRO monitors, and cross-functional study teams to ensure site-level activities and study documentation meet the highest standards of quality, consistency, and audit-readiness. The role combines hands-on monitoring expertise with ownership of eTMF quality control, trial oversight, and support of other clinical operations tasks as required.

The candidate should be comfortable both executing independently and working with a team in a fast-paced, clinical-stage biopharmaceutical environment. This position reports directly to the Director, Clinical Operations.

Clinical Trial Execution & Co-Monitoring

• Co-monitor site visits (selection, initiation, routine, and close-out) alongside CRAs or CRO partners to provide senior-level oversight, ensure consistency in monitoring quality, and support compliance with the protocol, ICH-GCP, and applicable regulations.
• Conduct independent quality checks of monitoring visit reports and source data verification/review (SDV/SDR) performed by junior CRAs or CRO monitors.
• Provide real-time coaching and feedback to CRAs during joint visits, helping calibrate monitoring approach and issue identification across the study team.
• Assess site performance, including protocol compliance, enrollment progress, and investigational product accountability, and elevate findings from co-monitoring visits as needed.
• Identify, document, and follow up on site-level issues, deviations, and corrective/preventive actions (CAPAs) surfaced during co-monitoring.
• Build and maintain strong working relationships with investigators and site staff, modeling best practices for less experienced monitors.
• Familiarity in execution of oversight tasks in support ofphase 2 and 3 clinical studies including but not limited to: essential document reviews, clinical report monitoring report reviews for other Trevi studies, review of informed consent document site and IRB requests for comments.

eTMF & Quality Control

• Own quality control review of the electronic Trial Master File (eTMF), ensuring documents are complete, accurate, and filed per the TMF reference model and study-specific plan.
• Track eTMF health metrics and proactively resolve gaps, misfiles, or missing documents ahead of inspections and audits.
• Support inspection and audit readiness by maintaining a consistently "always audit-ready" TMF.
• Partner with Regulatory Affairs and Quality Assurance to ensure document control practices align with company SOPs and regulatory expectations.

• Serve as a support role for the Director, Clinical Operations role between sites, CROs (if applicable), and internal study teams.
• Contribute to development and refinement of monitoring plans, visit report templates, and site management tools.
• Support development of study-level trackers and status reports for Clinical Operations leadership.
• Mentor and provide guidance to junior CRAs or clinical trial associates.
• Additional Duties as required.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Minimum of a bachelor’s degree in life sciences, nursing or related field.
  
  Advanced degree a plus.
• Minimum of
  -4-6 years of relevant clinical research experience in Biotech/Pharmaceutical, Med Device, CRO, or industry experience preferred. Must have prior experience with Phase 2 and Phase 3 trials.
• Demonstrated experience with eTMF systems and document quality control (experience with (Regulatory Information Management Systems (RIMS) platforms a plus)
• Strong working knowledge of GCP/ICH guidelines, FDA regulations, and applicable local/regional requirements for conducting clinical trials.
• Experience with EDC systems and remote/risk-based monitoring approaches.
• Prior experience supporting inspection readiness (FDA, EMA, or other health authority audits).
• Expertise with clinical monitoring required. Must have deep, hands-on knowledge of GCP-compliant site monitoring and issue identification. Extensive knowledge of clinical trial methods and…