Description
Overview: The Senior CRA (Sr. CRA) is responsible for the management of day-to-day aspects of Investigator site and CRA activities for the assigned study or studies. The Sr. CRA, in concert with the Project Leader, is accountable for the timely, quality, satisfactory, and cost-effective completion of the client's study. The Sr. CRA may manage a single service, monitoring-only study or assist in the management of a core group of CRAs on a cross-functional study.Responsibilities:
- In a matrix environment, manage, lead and motivate the assigned project CRAs to ensure the team's ability to fulfill their responsibilities in accordance with the project's contract, ICH GCPs and company Clinical Research procedures and SOPs
- Effectively manage and provide support to the clinical team in the conduct of the trials including site management and monitoring responsibilities
- Arrange for and perform periodic quality control visits with the CRAs as needed
- Review and approve CRA responses to quality assurance audits to ensure responses are appropriately addressing the issues, and that response and distribution are timely and in accordance with company standard operating procedures
Requirements:
- A four-year degree (preferably in a life science) or RN certification is required
- 3+ years of field monitoring experience with a sponsor or CRO
- 3+ years experience working with medical device or diagnostic clinical trials
- Travel: ability to travel up to 25 % during occasional peak periods
- Strong working knowledge of ICH GCP guidelines
To find out more about Real please visit www.realstaffing.com