Job Description
Sr. Clinical Research Associate
12-month contract
Onsite in Sunnyvale, CA
Responsibilities
- Support the successful execution of clinical studies by contributing to study design, documentation, and overall management.
- Lead and manage site start-up and activation processes, including regulatory document preparation, IRB/EC submissions, and clinical trial agreements.
- Conduct monitoring visits (qualification, initiation, interim, and close-out) and ensure protocol and regulatory compliance through source data verification and study oversight.
- Serve as the primary liaison for clinical sites, overseeing data entry, investigational device tracking, and issue resolution.
- Maintain and manage study documentation, including Trial Master File (TMF), clinical trial management systems (CTMS), and site payments.
Qualifications
- Experience implementing and managing medical device clinical trials.
- In-depth knowledge of ISO 14155, 21 CFR Part 11, 50, 54, 812, and ICH/GCP regulations.
- Proficiency in developing study documents (protocols, informed consent forms, CRFs/eCRFs, monitoring plans).
- Experience with clinical research budgeting and contract negotiation.
- Proficiency with Microsoft Office Suite, PDF applications, and Electronic Data Capture (EDC) systems.
- Experience with Clinical Trial Management Systems (CTMS).
- Prior experience in protocol and clinical section writing for regulatory submissions.
- Experience in medical device industry is required.
- Experience with IDE (pre-market) studies.
Job Tags
Contract work, Interim role, Work at office,