Intellectt INC
Location
Alameda, CA | United States
Job description
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:
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.
Education and Experience:
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.
Skills:
Strong teamwork, communication, and problem-solving skills.
Solid understanding of clinical trial processes and regulatory affairs.
Proficient with Microsoft Suite.
Travel Requirements:
Ability to travel 30-50%.
Job tags
Salary
