Also referred to as:
Clinical Research Programs Director, Clinical Trials Research Director
Requirements and Responsibilities
Clinical Research Director directs and oversees the team responsible for the design, administration, and execution of clinical research trials. Oversees and ensures adherence to established processes and procedures, FDA regulatory requirements, Good Clinical Practice (GCP) research standards, and JCAHO and International Conference on Harmonization (ICH) guidelines. Being a Clinical Research Director designs, develops, and implements clinical processes, procedures, and programs. May require an advanced degree. Additionally, Clinical Research Director may require ACRP or SOCRA certification. Typically reports to senior management. The Clinical Research Director manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. To be a Clinical Research Director typically requires 5+ years of managerial experience. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function.
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