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