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Clinical Project Manager III
Durham, NC 27701 United States
We are looking for talented and committed Clinical Project Managers to be part of our ever-growing team of professionals. If you are seeking to be part of an organization that provides meaningful work, fosters professional development, and enjoys a collaborative work environment, we want to hear from you!
Why Work for Us?
Duke Clinical Research Institute (DCRI) is committed to investing in its employees and their development! Here are some of the benefits we offer:
• Tuition reimbursement for employees and their children
• 403B and direct contribution
• Medical, dental and vision insurance
• Wellness program
• Flexible work schedules and work-from-home capability
• Ongoing training through online learning and in-person classes
• Access to events and programs at Duke University
• And more!
About the Job
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.
• 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 in preceptor 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 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.
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.**
North Carolina Biotechnology Center