Senior Clinical Research Associate

1d1 day ago

Travere Therapeutics

San Diego, US · Full-time · $95,000 – $124,000

About this role

This position reports to the Associate Director, Clinical Operations and is part of a global team inspired to make a difference in the lives of people living with rare disease. At Travere Therapeutics, we are dedicated to identifying, developing, and delivering life-changing therapies to the rare disease community.

With supervisor and Clinical Trial Manager oversight and mentoring, the individual will coordinate, track, and manage daily oversight activities for multiple clinical studies. This includes supporting both the internal project team and CROs to ensure successful study implementation and execution.

The role involves triaging, resolving, or escalating study issues to Clinical Operations Management as needed. The Senior CRA will attend Investigator Meetings, assist in creating clinical study protocols and informed consent forms, and collaborate with functional groups including Data Management and Pharmacovigilance.

We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment. Our work is rewarding—both professionally and personally—because we are making a difference for rare patients, and we stick by our values centered on patients, courage, community, and collaboration.

Requirements

Experience in clinical operations within the pharmaceutical or biopharmaceutical industry.
Ability to coordinate and manage daily oversight activities for multiple clinical studies.
Familiarity with ICH/GCP guidelines and regulatory requirements for clinical trials.
Proficiency with IRT/IXRS, EDC, and/or ePRO systems for remote monitoring of subject recruitment and treatment status.
Strong organizational skills to maintain study trackers, meeting materials, and documentation.
Ability to collaborate effectively with cross-functional teams including Data Management, Pharmacovigilance, and CROs.
Experience supporting the creation and maintenance of clinical study protocols, informed consent forms, and study-specific manuals or plans.

Responsibilities

Support daily oversight of full service CROs, clinical sites, and third-party vendors to ensure successful study implementation and execution.
Participate in study team meetings and review meeting minutes for accuracy and completeness; may coordinate study team meetings including scheduling and preparation of materials.
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.
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, and maintain Project Management trackers (e.g., Risks/Issues, Actions/Decisions, Frequently Asked Questions).
Oversee CRO monitoring activities to ensure compliance with study plans, SOPs, and ICH/GCP, and collaborate in the review of the Trial Master File (TMF).

Benefits

Be part of a global team inspired to make a difference in the lives of people living with rare disease.
Work in a collaborative, diverse, fast-paced environment focused on rare disease therapies.
Opportunity to contribute to life-changing therapies for the rare disease community.
Mentoring and oversight from Clinical Trial Manager and Associate Director, Clinical Operations.