Senior Clinical Research Associate
Travere Therapeutics · San Diego Metropolitan Area
- On site
- Full-time
- $124,000 / year
- San Diego Metropolitan Area
Job highlights
- Oversee clinical studies and CROs.
- Monitor study sites and patient recruitment.
- Manage study documentation and budgets.
- Ensure regulatory compliance.
- Collaborate with cross-functional teams.
About the role
Senior Clinical Research Associate
Join a global team dedicated to improving the lives of individuals with rare diseases at Travere Therapeutics. We are seeking passionate individuals to contribute to our mission of identifying, developing, and delivering life-changing therapies. If you thrive in a collaborative, diverse, and fast-paced environment and share our commitment to patients, courage, community, and collaboration, we encourage you to apply.
About Travere Therapeutics
At Travere Therapeutics, we are committed to rare diseases and strive to be a leading biopharmaceutical company. We forge new paths with courage and a shared goal of elevating science and service for rare patients. Our values guide us in our pursuit of innovation and hope for the global rare disease community.
Position Summary
Reporting to the Associate Director of Clinical Operations, this role involves coordinating, tracking, and managing daily oversight activities for multiple clinical studies. You will work under the guidance and mentoring of a supervisor and Clinical Trial Manager (CTM) to support both internal project teams and Contract Research Organizations (CROs).
Responsibilities
- Support daily oversight of full-service CROs, clinical sites, and third-party vendors to ensure successful study implementation and execution, with supervisor and CTM oversight.
- Participate in study team meetings, review minutes for accuracy, and may coordinate meetings including scheduling and material preparation.
- Triage, resolve, or escalate study issues to Clinical Operations Management as needed.
- Attend and participate in Investigator Meetings and study-specific training.
- Assist in creating and maintaining clinical study protocols, informed consent forms, and study-specific documentation.
- Monitor subject recruitment and treatment status remotely using IRT/IXRS, EDC, and ePRO systems.
- Track and manage study-related materials, including Investigational Product (IP) and laboratory samples.
- Maintain Project Management trackers for risks, issues, actions, decisions, and frequently asked questions.
- Collaborate with Data Management, Pharmacovigilance, and other functional groups for precise clinical study data review.
- Oversee CRO monitoring activities to ensure compliance with study plans, SOPs, and ICH/GCP, with supervisor and CTM oversight.
- Support the development of presentation slides, white papers, and dashboards for senior leadership and governance committees.
- Collaborate in the review of the Trial Master File (TMF) for quality and compliance.
- Manage and communicate study status, timelines, enrollment, quality metrics, regulatory documentation, and site start-up status for assigned clinical studies.
- Review site budgets, manage clinical study budgets, and collaborate with finance on reporting and projections, with supervisor and CTM oversight.
- Coordinate the submission, tracking, and management of CRO/vendor Confidential Disclosure Agreements (CDAs), contracts, and change orders, with supervisor and CTM oversight.
- Participate in the development of departmental initiatives and contribute ideas for enhancing efficiency and effectiveness.
- Assist with special projects such as SOP development, GCP compliance, process enhancements, and systems implementation.
Education and Experience Requirements
- Bachelor’s degree or equivalent in a biomedical, life science, or related field. Equivalent combinations of education and experience will be considered.
- Minimum of four (4) years of clinical operations experience in a pharmaceutical or CRO setting.
Additional Skills and Experience
- Embody Travere’s core values: Courage, Community Spirit, Patient Focus, and Teamwork.
- Experience with Phase 1, 2, or 3 trials, including site management (onsite or remote source data verification/monitoring).
- Ability to evaluate unpredictable scenarios and achieve project timelines by applying protocol understanding.
- Proficiency in Microsoft Office applications, IRT/IXRS, and Electronic Data Capture platforms.
- Working knowledge of global regulatory and compliance requirements (US CFR, EU CTD, ICH GCP).
- Strong problem-solving skills, sense of urgency, attention to detail, ability to work independently, and manage multiple priorities under pressure.
- Willingness to travel 10-20% domestically and internationally.
Key skills/competency
- Clinical Operations
- Clinical Research Associate
- CRA
- Study Management
- CRO Oversight
- Site Management
- ICH GCP
- Regulatory Compliance
- Clinical Trials
- Pharmaceutical Industry
Skills & topics
- Senior Clinical Research Associate
- Clinical Operations
- Clinical Trials
- CRA
- Site Management
- CRO Oversight
- GCP
- Regulatory Compliance
- Pharmaceutical
- Biotechnology
- Rare Disease
- San Diego
- Life Sciences
- Biomedical
How to get hired
- Tailor your resume: Highlight your 4+ years of clinical operations experience, focusing on pharmaceutical/CRO settings and Phase 1-3 trial involvement. Quantify achievements where possible.
- Craft a compelling cover letter: Emphasize your understanding of Travere's mission and values (patients, courage, community, collaboration) and how your skills align with the Senior Clinical Research Associate role.
- Prepare for behavioral questions: Be ready to discuss how you handle unpredictable scenarios, manage multiple priorities under pressure, and work independently, referencing your problem-solving skills and attention to detail.
- Demonstrate technical knowledge: Be prepared to discuss your experience with IRT/IXRS, EDC platforms, and global regulatory requirements like ICH GCP.
- Research Travere Therapeutics: Understand their focus on rare diseases and their patient-centric approach to further tailor your application and interview responses.
Technical preparation
Master EDC, IRT/IXRS, and ePRO systems.,Review US CFR, EU CTD, and ICH GCP.,Practice protocol interpretation and application.,Prepare for budget review and financial reporting.
Behavioral questions
Describe managing multiple priorities under pressure.,How do you handle unpredictable study scenarios?,Give an example of your problem-solving skills.,How do you work independently with limited oversight?
Frequently asked questions
- What is the target base pay range for a Senior Clinical Research Associate at Travere Therapeutics?
- The target base pay range for this Senior Clinical Research Associate position at Travere Therapeutics is between $95,000.00 and $124,000.00 annually. The final offer will depend on factors such as your experience, education, skills, and location.
- What are the primary responsibilities of a Senior Clinical Research Associate at Travere Therapeutics?
- As a Senior Clinical Research Associate at Travere Therapeutics, your primary responsibilities include overseeing clinical studies, managing CROs and clinical sites, monitoring subject recruitment, ensuring regulatory compliance, managing study documentation and budgets, and collaborating with cross-functional teams.
- What educational background is required for the Senior Clinical Research Associate role at Travere Therapeutics?
- A Bachelor’s degree in a biomedical, life science, or related field is required. An equivalent combination of education and applicable job experience may also be considered for the Senior Clinical Research Associate position.
- Does Travere Therapeutics offer remote work options for the Senior Clinical Research Associate position?
- The Senior Clinical Research Associate position is located in San Diego and the description does not explicitly state remote work is an option. While some monitoring may be remote, the role appears to be primarily based on-site in San Diego.
- What type of experience is essential for a Senior Clinical Research Associate at Travere Therapeutics?
- Essential experience for this role includes a minimum of four years in clinical operations within a pharmaceutical or CRO setting, with a strong preference for Phase 1, 2, or 3 trial experience and site management expertise.
- How does Travere Therapeutics support employee well-being and professional growth for a Senior Clinical Research Associate?
- Travere Therapeutics offers comprehensive total rewards, including premium health, financial, and work-life benefits, wellness programs, retirement plans with employer match, and generous paid time off. Their compensation package combines cash and long-term incentives to recognize and reward employees.
- What are Travere Therapeutics' core values that a Senior Clinical Research Associate should embody?
- A Senior Clinical Research Associate at Travere Therapeutics should embody the company's core values: Courage, Community Spirit, Patient Focus, and Teamwork. These values are central to their mission of serving the rare disease community.