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Senior Clinical Research Associate

$95k - $124k

Travere Therapeutics

Department: 106600 Clinical Operations | Location: San Diego Position Summary This role reports to the Associate Director, Clinical Operations and involves coordinating, tracking, and managing daily oversight of multiple clinical studies. The candidate will support internal project teams and CROs. Responsibilities Coordinate daily oversight of full-service CROs, clinical sites, and third-party vendors to ensure successful study implementation. Participate in study team meetings, review minutes for accuracy, and coordinate meeting logistics (scheduling, materials, distribution). Triage, resolve, or elevate study issues to Clinical Operations Management. Attend Investigator Meetings and study‑specific training for assigned studies. Assist in creating and maintaining clinical study protocols, informed consent forms, and study‑specific binders/manuals/plans/tools. Monitor subject recruitment and treatment status via IRT/IXRS, EDC, or ePRO systems. Track and manage study‑related materials including IP and laboratory samples. Maintain Project Management trackers (Risks/Issues, Actions/Decisions, FAQs). Collaborate with cross‑functional groups (Data Management, Pharmacovigilance, etc.) to review clinical study data. Oversee CRO monitoring activities ensuring compliance with study plans, SOPs, and ICH/GCP. Support development of presentations, white papers, and dashboards for senior leadership. Collaborate in reviewing the Trial Master File to ensure documentation quality. Manage study status, timelines, enrollment, quality metrics, regulatory documentation, and site start‑up status. Review site budgets, manage clinical study budgets, and provide input for financial reporting. Coordinate CRO/vendor Confidential Disclosure Agreements (CDAs), contracts, and change orders. Contribute ideas to department initiatives and goals and assist with special projects such as SOPs, GCP, process enhancements, outsourcing, Sunshine Act, systems implementation, and training. Education / Experience Requirements Bachelor’s degree or equivalent in a biomedical, life science, or related field. Minimum four (4) years of clinical operations experience in a pharmaceutical or CRO setting. Additional Skills / Experience Phase I‑III trial experience, including site management (onsite or remote data verification/monitoring). Ability to evaluate unpredictable scenarios and achieve project timelines. Proficient with Microsoft Office, IRT/IXRS, and Electronic Data Capture platforms. Knowledge of global regulatory and compliance requirements (US CFR, EU CTD, ICH GCP). Strong problem‑solving skills, sense of urgency, attention to detail, and ability to work independently with limited oversight. Ability to manage multiple priorities under time and resource pressures. Travel 10‑20% domestic and international. Benefits Our benefits include premium health coverage, financial, work‑life and well‑being offerings, wellness and employee support programs, life insurance, disability benefits, retirement plans with employer match, and generous paid time off. Compensation Target base pay range: $95,000.00 – $124,000.00. Compensation includes base pay, short‑term incentive, and long‑term incentive (company stock). Equal Employment Opportunity Statement Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer. If you require a reasonable accommodation, please contact us at View email address on click.appcast.io. #J-18808-Ljbffr Travere Therapeutics

Vacancy posted 4 days ago
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