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Job Classification: Contract
The following responsibilities will be required for the Regional Clinical Lead on the Medical Imaging Project
-As a member of the clinical project team, provides CRO(s) and vendors oversight for managed clinical trials. This includes and is not limited to planning, organizing, communicating, and implementing study objectives for study protocols.
-As a member of the clinical project team, may be assigned responsibility for the management of oversight leads for US and potentially other countries.
-Primary contact for management of operational activities of vendors
-Participates in clinical team meetings.
-Prepares and or review a variety of documents including protocol, CRF, informed consent form, operations manual, monitoring plan, and other documentation required for the conduct of a clinical trial such as medical imaging manuals.
-Assist with the preparation of required regulatory documents, such as IND/NDA annual reports, updating of the IB, and final study reports for assigned protocol(s)
-Manages day-to-day clinical operations, including management of sites and coordination of team member activities for assigned study regions.
-Manages oversight monitoring for assigned study regions
-Initiates the development of a template site budget for management review and approval.
-Coordinate the completion of Patient Accrual Logs for Finance
-Participates in conducting meetings (i.e. CRA Training, Investigator, etc.), including advance preparation, presentations, problem resolution, and follow-up.
-Participates in development of training programs and training of affiliate and CRO staff working under OPDC and other SOPs
-Reviews essential documents for completeness and accuracy and prepares all required documentation required for IMP release and ongoing trial master file maintenance.
Join Aerotek Scientific®LLC, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law.
- CLINICAL STUDY MANAGEMENT, CLINICAL TRIAL MONITORING