Senior Clinical Research Associate (SCRA)

Position Title: Senior Clinical Research Associate

About the Organization

This international biotech company is dedicated to advancing therapies for individuals with rare and complex medical conditions that are not readily addressed by existing treatments. With one approved product and a robust pipeline of clinical studies, the company continues to grow-achieving consistent revenue increases and delivering breakthrough solutions for patients with limited options. Join a dynamic and talented team that values innovation, collaboration, and a strong people-first culture. Apply today to be part of a mission-driven organization making a real difference.

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