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,

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