Clinical Trials Project Leader III (Office Based) - NCR
Novella Clinical Resourcing is Seeking Clinical Trials Project Leader III for Office Based Position in North Carolina:
Opportunities for Senior Project Managers with experience in fulllife cycle clinical trials project management, Phase II-IV multi-centerresearch projects, managing multiple projects at a time, and a variety of therapeuticareas.
- 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 Is and IIs.
- 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 staffs 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.
Work requires graduationfrom an accredited degree program providing clinical training as a RegisteredNurse (RN), Physician’s Assistant (PA) orPharmacist plus three years of healthcare experience; or one of the followingequivalents: 1. Completion of an allied health degree (e.g., RespiratoryTherapy, Radiologic Technology, Licensed Practical Nurse) or Associates degreein Clinical Trials Research related curriculum plus a minimum of six yearshealthcare experience; or2. Completion of a master’s degree in Public Health,Health Administration or a related area with two years directly relatedclinical trials research experience; or3. Completion of a bachelor’s degree plus a minimum offour years directly related experience in clinical trials research; or4.Completion of a bachelor’s degree plus a minimum of five years closely relatedresearch experience. State of North Carolina license may be required.
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