- 4−year college degree in science or RN with clinically related experience
- At least four years clinical trial experience, with a significant amount of monitoring experience and two years managerial/supervisory experience
- Specialized knowledge of clinical monitoring operations/functions, applicable regulatory compliance guidelines, contract research service operations and medical terminology
- Demonstrated ability to handle multiple competing priorities
- Proficient in computer use. EDC experience helpful.
- Any USA location as is home office.
The Lead CRA (LCRA), is responsible for management of the day-to-day aspects of Investigator site and Clinical Research Associate activities for the assigned study or studies. The LCRA, in concert with the Project Leader, is accountable for the timely, quality, satisfactory, and cost-effective completion of the client’s study. The LCRA may manage a single service, monitoring only the study or assist in the management of a core group of CRAs on a limited services, small regional or global cross-functional study.
- 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, contract amendments, ICH GCPs and Theorem Clinical Research procedures and SOPs
- Effectively manage and provide support to CRAs in the conduct of the clinical trial including covering site management and monitoring responsibilities during vacations, CRA team member transitions and other emergency visit situations as needed
- Arrange for and perform periodic quality control visits with the CRAs as specified in the contract
- 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.
Theorem Clinical Research is one of the foremost providers of comprehensive CRO services with offices in more than 30 countries and a...