JOB DESCRIPTION: Responsible for directing and managing large and highly complex clinical research groups. With support from operational leadership, assesses team performance, manages distribution of staff workload, and ensures compliance amongst staff. Supervises staff to include performance management and development, recruitment, on-boarding. May serve as a back-up and fill temporary portfolio management needs. Works with clinical research leadership to ensure alignment between team needs and department infrastructure to facilitate strategic planning. Provides oversight of the clinical research portfolio, including reviewing potential research opportunities with the Medical Director and Principal Investigators (PI) to evaluate alignment with portfolio development goals, assists in the selection process, and opening of appropriate studies. Supports the protocol feasibility review process. Tracks team metrics including trial accruals, budget activity, and reports metrics to operational leaders on a regular basis. Supports PIs and staff to ensure GCP and institutional compliance for all study protocols. Ensures coordinators are adhering to GCP including confirmation of subject eligibility, proper informed consent process & documentation, and protocol adherence. Performs quality oversight to include monitoring progress of screening, enrollment, and data submission. Ensures compliance with department policies and procedures. Identifies barriers to timely study activation, efficient coordination, and identifies/implements potential solutions. Ensures timeliness and accuracy of clinical research information and data in all databases and tracking systems. Provides support in engaging relevant providers (physicians, advance practice providers, clinic nurses, staff) to ensure that clinical issues at all points of contact, are addressed in a timely and compliant fashion. Assists with the development and implementation of departmental specific role-based curriculum for new employees. Contributes to the development and refinement of standard operating procedures (SOPs) and assists with SOP training. Contributes to the development and execution of educational in-services pertinent to the performance of high-quality clinical research. Contributes to the development of study-level corrective action plans, subsequent implementation, and documentation of progress of plans. Actively participates in meetings, task forces and committees as assigned. Promotes and advances the clinical research activities in a safe, compliant, effective, efficient, and collegial manner. Other duties as assigned.
MINIMUM QUALIFICATIONS: Bachelor's degree in a scientific, health-related or business administration program required and seven (7) years of clinical research experience, with at least four (4) years of Clinical Research Coordinator or Clinical Research Nursing experience OR an equivalent combination of education/experience. ACRP/SoCRA (or equivalent) certification required within one (1) year of hire. Prefer Master's degree and experience leading or managing teams. |
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Human Resources