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 Clinical Research Institute (DCRI); perform a variety of duties involved in the organization, documentation and compilation of clinical research data.
Work Performed: 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 DCRI; perform a variety of duties involved in the organization, documentation and compilation of clinical research data; function inpreceptor capacity for Clinical Trials Project Leaders I and II. 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, timelines, 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 asappropriate. 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. The above statements describethe general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
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:
1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of seven years healthcare experience; or 2. 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 3. Completion of a bachelor's degree plus a minimum of five years directly related experience in clinical trials research; or 4. Completion of a bachelor's degree plus a minimum of six years closely related research experience.
**State of North Carolina license may be required.**