Position Summary
The CRA B will assist in the clinical execution and management of all aspects of assigned clinical studies. This includes but not limited to planning and implementation of clinical studies from concept to clinical study report per timelines and quality standards.

• Working knowledge of GCP, Clinical and Regulatory Affairs.
• Perform study site visits (SQV, SIV, IMV, COV), ensuring compliance to the Study Protocol, Good Clinical Practices (GCPs), ICH guidelines, Federal Regulations, department procedures and applicable regulatory requirements, generating monitoring trip reports, and track resolution of action items.
• Responsible for ensuring shipment of study devices and supplies to clinical sites and performing study device accountability.
• Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), selection and training of investigator sites, planning and running study meetings, evaluation, selection, and training of new study investigators.
• Maintain and audit Trial Master File to ensure inspection readiness.
• Participate in the interim and final reviews of study data in preparation of regulatory submissions.
• Involved in the preparation of all applicable documents required for the conduct of the study (such as Trial Master File (TMF), Clinical Protocols and Reports).
  

Education And Experience

• BS degree in life sciences with three years of experience as a CRA or CRC or combination of appropriate education and experience required.
• Must have 3+ years of relevant experience in site monitoring, clinical trial practices and regulations.
• Experience in conducting medical device and/or in-vitro diagnostics studies. Pharmaceutical background may also be considered.