CRA

Responsible for the delivery of the studies at allocated investigator sites. Accountable for study start-up and regulatory maintenance until study close out. Perform site selection (if applicable), initiation, monitoring and close-out visits, while serving as the main point of contact for clinical sites.

Tasks include:

• Submission of proper application/documents to EC/IRB and to Regulatory Authorities including Yakar for start-up and for the duration of the study.
• Site training on protocol procedures.
• Oversee Investigational product inventory and accountability according to clinical department SOPs
• Source data verification and case repot form (CRF) data cleaning including data query generation and resolution.
• Ensuring recruitment is according to project timelines.  
• Ensure quality. Evaluate the quality and integrity of the reported data and site performance.
• Responsibility for pharma related finance administration.
• Official BOL Pharma representative at the “Yakar”- Handling “Yakar” activity including licensing for sites and patients   with respect to clinical trials.