Sr. CRA
Senior Clinical Specialist
$120k-$150k | Bay Area, CA | 3 days on-site
We're working with a growing, science-driven biopharmaceutical company focused on developing innovative therapies across rare and complex diseases. With a strong global footprint and a collaborative, cross-functional culture, this organization is scaling its Clinical Affairs team and looking to bring on a Senior Clinical Specialist to support ongoing and upcoming studies. As a Senior Clinical Specialist, you will play a key role in the execution and delivery of clinical studies across multiple programs, partnering closely with Clinical Operations and Study Leadership.
Responsibilities
- Lead end-to-end site management activities including start-up, monitoring, and close-out, ensuring studies are delivered on time and in compliance with GCP and regulatory standards
- Oversee site performance, maintain study tracking, and proactively identify risks with mitigation strategies to ensure quality and timelines
- Review source data and CRFs, ensure proper documentation (TMF/ISF), and maintain overall study data integrity
- Collaborate cross-functionally with internal teams and external vendors to ensure alignment and smooth study execution
- Support regulatory submissions, audit/inspection readiness, and mentor junior CRAs through training and co-monitoring
Qualifications
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related discipline
- 3+ years of CRA/clinical site monitoring experience
- Strong knowledge of ICH-GCP guidelines and regulatory requirements
- Proven ability to manage clinical sites independently across study phases
- Experience with study start-up, site selection, and monitoring activities
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