CLINICAL TRIALS PROJECT LEADER III, DCRI Gov't & Networks
School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Develop, coordinate, and implement research and administrative strategies essential to the successful management of phase II, III and IV clinical trials research projects conducted by principal investigator(s) at Duke University Medical Center; perform a variety of duties involved in the organization, documentation and compilation of clinical research data; function in preceptor capacity for Clinical trials Project Leader I’s and Project Leader II’s.
Position Responsibilities & Key Tasks:
Develop, coordinate, and implement research and administrative strategies essential to the successful management of phase II, III and/or IV clinical trials research projects conducted by principal investigator(s) at Duke University Medical Center; perform a variety of duties involved in the organization, documentation and compilation of clinical research data; function in preceptor capacity for Clinical Trials Project Leader I’s and II?s.
Develop systems for the establishment and refinement of guidelines in the collection of clinical data and administration of clinical trials; design and evaluate alternative methodology as necessary
Advise and assist principal investigator and other team members in the development of plans, time lines, and processes for clinical research studies; coordinate the ongoing analysis and modification of protocols; recommend amendments to study protocols as appropriate.
Confer with site coordinators and physicians to explain protocol and to elicit compliance with regulations; assure adherence to Federal Drug Administration and protocol guidelines; identify potential problems and/or inconsistencies and take action as appropriate
Coordinate and lead the work of the Project Leader I and II staff and research team and provide feedback to staff’s supervisor on a routine basis; conduct cross functional research team meetings as needed. Advise and assist the principal investigator in initial contacts and development of relationships with outside partners and internal functional groups for potential projects including trial budget and contract negotiations. Perform other related duties incidental to the work described herein.
Experience directly related to Clinical Trials and or Clinical Trials Administration strategies is highly preferred
Minimum Qualification required for the position
Education and Experience
Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician’s Assistant (PA) or Pharmacist plus four years of healthcare experience; or one of the following equivalents:
- Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, and Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of seven years healthcare experience; or
- Completion of a master’s degree in Public Health, Health Administration or a related area with three years directly related clinical trials research experience; or
- Completion of a bachelor’s degree plus a minimum of five years directly related experience in clinical trials research; or
- Completion of a bachelor’s degree plus a minimum of six years closely related research experience.
**State of North Carolina license may be required. **
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