Senior Clinical Research Associate

Responsibilities

• With supervisor and Clinical Trial Manager (CTM) oversight and mentoring, supports daily oversight of full service CROs, clinical sites, and third-party vendors to ensure successful study implementation and execution.
• Triage, resolve, or escalate study issues to Clinical Operations Management as needed.
• Attend and participate in Investigator Meetings and study-specific training for assigned studies.
• Assist in the creation and maintenance of clinical study protocols, informed consent forms, and study-specific binders/manuals/plans/tools to ensure quality and deliverables are met across assigned studies.
• Monitor subject recruitment and treatment status remotely through IRT/IXRS, EDC and/or ePRO systems to maintain up to date tracking and oversight of sites and patients.
• Track and manage study-related materials including IP and laboratory samples.
• Maintain Project Management trackers (e.g., Risks/Issues, Actions/Decisions, Frequently Asked Questions).
• Collaborate with other functional groups including Data Management, Pharmacovigilance, and others to ensure precise review of the clinical study data.
• With supervisor and Clinical Trial Manager (CTM) oversight and mentoring, oversee CRO monitoring activities to ensure compliance with study plans, SOPs, and ICH/GCP.
• Support the development of presentation slides, white papers, and dashboards reviewed by senior leadership and governance committees.
• Collaborates with other functional groups in the review of the Trial Master File (TMF) to ensure quality of the documentation and compliance with study plans, SOPs, and ICH/GCP.
• In conjunction with CTM and CRO, manages and communicates study status, timelines/critical deliverables, enrollment, quality metrics, regulatory documentation, and site start‐up status for assigned clinical studies.
• With supervisor and Clinical Trial Manager (CTM) oversight and mentoring, review site budgets, manage clinical study budgets, and collaborate with finance to provide input into financial reporting and projections.
• With supervisor and Clinical Trial Manager (CTM) oversight and mentoring, responsible for submission, tracking, and coordinating CRO/vendor Confidential Disclosure Agreements (CDAs), contracts, and change orders.
• Actively participates in the development of department initiatives; contributes ideas when asked on department initiatives and goals that will make a difference to the efficiency and effectiveness of Clinical Operations.
• Assist with special projects for operations/departmental initiatives such as SOPs, GCP, process enhancements, outsourcing, Sunshine Act, systems implementation, training, etc.
• Education/Experience Requirements:
• Bachelor's degree, or equivalent, in a biomedical, life science, or related field of study. Equivalent combination of education and applicable job experience may be considered.
• Minimum four (4) years of clinical operations experience in a pharmaceutical or CRO setting.
• Additional Skills/Experience:
• The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork.
• Phase 1, 2 or 3 trial experience including site management (onsite or remote source data verification/monitoring), or closely

Benefits

Additional Information

Department: 106600 Clinical Operations Location: San Diego Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding - both professionally and personally - because we are making a difference. We are passionate about what we do. We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission - to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community. At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients . Position Summary: This position reports to the Associate Director, Clinical Operations. With supervisor and Clinical Trial Manager (CTM) oversight and mentoring, the individual will coordinate, track, and manage daily oversight activities for multiple clinical studies to support both the internal project team and the CROs.

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