Clinical Research Associate (Medical Device) – On-site in Sunnyvale, CA
Location: Sunnyvale, California
Job Type: Contract (12-month)
Work Mode: On-site
Compensation: Up to $120,000 per year
Company: GForce Life Sciences
Job Summary
GForce Life Sciences is actively seeking a Clinical Research Associate (CRA) for a 12-month on-site contract in Sunnyvale, CA. The CRA will play a critical role in managing clinical studies for medical device trials, ensuring regulatory compliance, site management, and successful execution of study objectives. This opportunity is ideal for professionals experienced in IDE/pre-market studies and FDA-regulated medical device trials.
Key Responsibilities
Lead and support end-to-end execution of medical device clinical studies
Manage regulatory documents, IRB/EC submissions, and site activation
Conduct monitoring visits (initiation, interim, close-out) and perform SDV
Liaise with clinical sites for tracking investigational devices and resolving issues
Maintain Trial Master File (TMF), CTMS, and handle site payments
Develop essential study documents including protocols and CRFs
Contribute to regulatory submission content related to clinical trials
Required Skills & Qualifications
Experience managing clinical trials in the medical device industry
Strong knowledge of ISO 14155, 21 CFR Parts 11, 50, 54, 812, and ICH/GCP
Hands-on experience with EDC systems and CTMS
Proficiency with Microsoft Office and PDF editing tools
Prior experience with IDE (pre-market) studies
Familiarity with clinical trial budgeting and contract negotiation
Skilled in writing protocols and regulatory documents
Perks & Benefits
Competitive contract salary up to $120K annually
Hands-on experience in FDA-regulated medical device trials
Opportunity to work with a dynamic, mission-driven team
Exposure to complex regulatory environments and global standards
About GForce Life Sciences
GForce Life Sciences is a specialized life sciences consultancy delivering high-quality talent for pharmaceutical, biotech, and medical device organizations. With deep industry knowledge and a focus on regulatory, clinical, and R&D roles, GForce empowers clients to meet complex project goals with agility and precision.
Work Mode: On-site in Sunnyvale, CA
Job Type: 12-month contract
Call-to-Action
If you are an experienced Clinical Research Associate seeking to contribute to meaningful medical device innovation, apply now to join GForce Life Sciences in Sunnyvale. This is your chance to drive regulatory success and clinical advancement in a cutting-edge environment.
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