Provides direct supervision of staff; prepares operational reports and assists in providing Winship specific education and training. Responsible for direct oversight and supervision of Clinical Research Nurses, Clinical Research Associates, Research Interviewer, and Data Coordinators (Clinical Research Staff). Hires, trains, and evaluates staff. Tracks and assures timely management of staff effort reporting for financial management. Assists the director in the understanding and applying the business model as needed. Supports and assists in research coordination as needed. Reviews site monitoring visits and responds to all exit reviews. Develops, implements and maintains SOPs to ensure timely reporting of adverse events, serious adverse events and unanticipated problems to the Winship Data Safety Monitoring Committee. Monitors the timeliness of response to all sponsors request for queries by working groups. Develops strategies to maximize timely completion of CRF's within the program. Incorporates the use of ONCORE in daily operations. Integrates processes to ensure subject data in Oncore and ERMS are updated in a timely manner.
Holds staff accountable for timely and accurate data updates. Provides education to the Winship community and Emory personnel in all aspects of clinical trials. Helps develop Winship specific minimum learning standards/requirements for Clinical Coordinators and physician-investigators, and maintains appropriate training records for participants. Works with clinical staff in developing and implementing patient education resources for clinical trials. Develops an integrated, Winship specific orientation program, and maintains appropriate training records for participants. Collaborates with Emory Healthcare Nursing and Office of Quality in developing protocol specific materials for the orientation and education of clinical staff in the conduct of clinical research protocols. Demonstrates knowledge of and competency in all regulatory requirements (FDA, GCP, ICH). Responsible for regulatory compliance at all levels. Performs other responsibilities as required.
MINIMUM QUALIFICATIONS: Master's degree in nursing and five years of progressively responsible research, nursing, clinical trials, or related experience which includes supervisory responsibility. Licensed as a nurse in the State of Georgia. A research certification is preferred.