Description
In this role, the CRA is responsible for the timely production of high quality data, adhering to the standards set by the Company/Sponsor in the Standard Operating Procedures for clinical studies. The CRA, in concert with the Project Leader, is accountable for the timely, quality, satisfactory, and cost-effective completion of the client's study.RESPONSIBILITIES
- Identifies potential investigational sites
- Coordinates and performs comprehensive site management, including ISF/TMF maintenance and site correspondence
- Conducts pre-study, initiation, interim and close out monitoring visits
- Produces comprehensive visit, status and telephone contact reports
- Resolves data issues and audit issues
- Adheres to study timelines and budget
- Mentors other CRAs
- Collects high quality essential documents and supports completion of ethics committee and regulatory submissions (if applicable per region)
EDUCATION/EXPERIENCE REQUIREMENTS:
- Minimum of two-plus years regional monitoring experience (CRO and Pharma environment preferred)
- A four-year degree, preferably in a life science, nursing, or related discipline
- Clinical research experience in one or more of the therapeutic areas mentioned below
- Located within 50 miles of a major airport.
- Experience with Oncology, Device/Cardiac Device, or Dialysis is strongly preferred. Other complex therapeutic experience considered.