Role: Clinical Research Associate (CRA) - B

Location: Alameda, CA - 100% onsite role

Duration: 6 Months

The CRA B will assist in the execution and management of clinical studies, overseeing all aspects from planning to clinical study report completion, ensuring adherence to timelines and quality standards.

Education and Experience:

• BS in life sciences with 3+ years as a CRA or CRC, or equivalent education and experience.
• Experience in site monitoring and clinical trials, particularly with medical devices or in-vitro diagnostics.
• Ability to travel 30-50%.

Skills:

• Strong teamwork, communication, and interpersonal skills.
• Solid understanding of clinical trial processes, including data management and reporting.
• Problem-solving, project management, and organizational skills.
• Proficiency in GCP and Microsoft Suite.

Key Responsibilities:

• Conduct medical device clinical studies, ensuring compliance with regulations.
• Perform study site visits, manage study device shipments, and assist with study planning.
• Maintain Trial Master File and participate in data review and regulatory submissions.
• Communicate study progress to management and ensure timely project delivery.
• Engage in preparation of clinical documentation and respond to audits.