Senior Clinical Research Associate

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.

Duties and Responsibilities

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 escalate 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 of phase 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.

Cross-Functional Collaboration

• 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.

Qualifications

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.

Education and Experience:

• 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 procedures along with a proven background in clinical research required.

Competencies

• Able to read, comprehend, write, and speak English fluently.
• Excellent written and verbal communication and interpersonal skills. Able to communicate complex information clearly and succinctly, both in writing and orally.
• Strong influencing, negotiating and problem-solving skills, including across functional, geographical and cultural boundaries.
• Must be adaptable with excellent organizational and time management skills. Ability to thrive in a fast-paced clinical-stage environment and work effectively toward numerous deadlines.
• Attention to detail. Must be able to catch discrepancies and gaps that could jeopardize inspection readiness.
• High level of quality and compliance. Will need to ensure eTMF and study documentation meet the highest standards of accuracy and audit-readiness.
• Model of integrity, professionalism, and confidentiality.
• Strong computer skills, including Microsoft Office (Teams, Word, Excel, Outlook), Zoom and Internet. SharePoint experience a plus.
• Ability to work independently and in a team environment to contribute to the achievement of program objectives.

Physical and Visual Requirements:

While performing the duties of this job, the individual is regularly required to use computers and office equipment, manipulate documents, work in an office environment and in clinical settings. This position requires the ability to primarily work remotely and travel domestically regularly up to 25% of the time in support of clinical study activities. The individual may experience prolonged periods of sitting. The employee may occasionally move materials up to 15 pounds.

Note: This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Trevi reserves the right to modify, change or add to the position's job duties and responsibilities as business needs may require. This document does not create an employment contract, implied or otherwise, other than an "at will" relationship.

Trevi Therapeutics, Inc. is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Trevi considers applicants for employment without regard to, and does not discriminate on the basis of, an individual's sex, race, color, religion, age, disability, status as a veteran, or national or ethnic origin; nor does Trevi discriminate on the basis of sexual orientation or gender identity or expression.