Clinical Research Assoicate
Role: Clinical Research Associate (CRA) - B
Location: Alameda, CA - 94502
Duration: 06+ Months
Shift Timings: 8 am to 5 pm
Job Summary
The CRAII/Sr. CRA will support medical device clinical studies, ensuring compliance, managing site visits, and contributing to cross-functional teams. Responsibilities include study start-up, device shipment management, and maintaining the Trial Master File.
Key Responsibilities
Location: Alameda, CA - 94502
Duration: 06+ Months
Shift Timings: 8 am to 5 pm
Job Summary
The CRAII/Sr. CRA will support medical device clinical studies, ensuring compliance, managing site visits, and contributing to cross-functional teams. Responsibilities include study start-up, device shipment management, and maintaining the Trial Master File.
Key Responsibilities
- Conduct medical device trials and perform site visits.
- Oversee clinical monitoring, study start-up, and device accountability.
- Assist in planning study conduct, designing CRFs, and managing CROs.
- Review clinical data listings and contribute to study data reviews.
- Prepare study documents and collaborate on audits and FDA inquiries.
- BS degree with 5+ years of relevant experience, or MS degree with 3+ years, or PhD with 2+ years.
- 5+ years of experience in site monitoring, clinical project management, and regulatory practices.
- Experience in medical device and/or in-vitro diagnostics studies.
- Strong teamwork, communication, and problem-solving skills.
- Solid understanding of clinical trial processes and regulatory affairs.
- Proficient with Microsoft Suite.
- Ability to travel 30-50%.
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Seniority level
Mid-Senior level -
Employment type
Contract -
Job function
Research, Analyst, and Information Technology -
Industries
Staffing and Recruiting
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