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.

Key Qualifications:
• 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.
• Ability to help ensure eTMF and study documentation meet the highest standards of accuracy and audit-readiness.
• Model of integrity, professionalism, and confidentiality.
• 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.

Note:
Please review the full job description accessible on trevitherapeutics.com/careers/. This posting in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position.

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.