Senior CRA
Position Title: SR CRA
About the Organization
This international biotech company is dedicated to advancing therapies for individuals with rare and complex medical conditions not ready available to the general public. With one product already being approved and multiple studies in their pipeline, this company has grown to exciting new heights from increasing their revenue year after year to creating breakthrough solutions for those who have no alternatives. Join this exciting, talented team of experts who shape innovation and success who recognizes the importance of people and culture. Apply today!
Role Summary
The SR. CRA will play a key role in supporting clinical development and post-market activities. This position involves coordination with study sites, document management, and ensuring compliance with regulatory and quality standards.
Primary Responsibilities
Serve as a liaison between clinical sites and internal teams for both investigational and marketed products
Oversee collection and maintenance of essential regulatory and trial documentation
Monitor safety data and support pharmacovigilance reporting processes
Coordinate logistics for clinical supplies and site payments
Track project timelines and site performance metrics
Prepare submissions for ethics and regulatory bodies
Participate in internal and external meetings, including investigator and audit sessions
Contribute to internal communications and knowledge-sharing initiatives
Key Performance Indicators
Timely resolution of site-level issues
Accuracy and completeness of clinical documentation
Support for safety and quality investigations
Maintenance of organized and audit-ready trial files
Qualifications & Experience
Bachelor's degree in life sciences, nursing, pharmacy, or a related discipline (advanced degree preferred)
Familiarity with international clinical research standards (e.g., ICH-GCP)
Prior experience in clinical operations, site management, or regulatory affairs
What You'll Gain
Competitive compensation and benefits package
Exposure to global clinical development and commercial operations
Opportunities to collaborate with leading experts in the field
A dynamic, mission-driven work environment
Reports To:
* Clinical Programs Manager
* Regional Operations Director
* Clinical Affairs Supervisor
Employment Type: Full-Time, Permanent
Location: San Francisco Bay Area (Hybrid: Remote with On-Site Requirements)
Work Schedule: Monday-Friday, 9:00 AM - 5:00 PM
Travel: Occasional domestic travel required
Compensation - $110K - $130K
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
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That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
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