Job Description

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.

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