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Senior Clinical Research Associate
When you’re ready to join a company that’s as dedicated to excellence as you are, THINK THEOREM.
Theorem Clinical Research is currently searching for talented, dedicated Senior CRA's. Successful candidates will be located in the Detroit, MI area , within 50 miles of a major airport.
In this role, the Senior CRA 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 Senior CRA, in concert with the Project Leader, is accountable for the timely, quality, satisfactory, and cost-effective completion of the client’s study. The Senior CRA 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
We require a four-year degree, preferably in a life science, RN, or equivalent experience, along with a minimum of four years' field monitoring experience (CRO environment preferred).
Experience with Phase I Oncology, NICU or other in-patient, or device/cardiac-device strongly preferred. Other complex therapeutic experience considered.
For more information about our Clinical Operations and Monitoring group, please visit:
For more information about Theorem Clinical Research, please visit:
At Theorem, you’ll join a team of like-minded individuals headed by some of the most dynamic and influential leaders in drug and medical device development today. You’ll work on cutting-edge global research projects in a fast-paced but collegial atmosphere where you’ll have the opportunity to make meaningful — and acknowledged — contributions. You’ll have opportunities to grow personally and professionally and abundant room for advancement along with generous incentive programs.
Theorem Clinical Research Inc. is a leading midsized provider of comprehensive clinical research and development services with offices in more than 30 countries and a customer base comprised of some of the world's top pharmaceutical, biotech and medical device companies. As a forerunner in medical device and drug-device combination trials with notable capabilities in pharmaceuticals and biologics, Theorem offers deep expertise in a broad range of therapeutic areas and in all phases of development. With some of the industry's top scientists and most advanced clinical analytics capabilities, Theorem ensures smooth-running, successful trials. For the full-service, right-size global research partner, don't think twice. THINK THEOREM .
Theorem Clinical Research is an equal opportunity employer, M/ F/ D/ V
Theorem Clinical Research - 7 months ago
Theorem Clinical Research is one of the foremost providers of comprehensive CRO services with offices in more than 30 countries and a...