CLINICAL TRIALS PROJECT LEADER I, DCRI.
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.
POSITION IS RESEARCH/GRANT FUNDED
Develop, coordinate, and implement research and administrative strategies essential to the successful management of phase I, II, III, and IV clinical trials research projects as well as registries and observational studies 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.
Primary Responsibilities and Tasks:
- With guidance, recommend guidelines and refinement of guidelines in the collection of clinical data and administration of clinical trials, registries, and/or observational studies; assist in the determination of guidelines for new protocols.
- Develops improvement in processes to increase efficiencies.
- Responsible for oversight, innovates and adapts research processes and guidelines including designs, methods and data.
- Anticipates and addresses simple operational problems at any study phase.
- As part of the problem solving process, recognizes and considers the long-term benefits, risks and consequences of different solutions to the project and other project team members (including sub-study personnel, sponsors and subcontractors).
- Recognizes when issues need to be escalated to senior management in a timely manner. Works with senior management to propose resolutions and leads these initiatives with assistance as needed.
- Demonstrates a flexible and adaptable problem-solving approach to the operational needs of projects and all project team members (including sponsors and subcontractors).
- Consistently recognizes the contributions of other team members.
- Exhibits inclusive approach to decision making and goal setting processes.
- Fosters group ownership of and enthusiasm for project.
- With oversight, assigns specifics tasks in order to challenge team members while encouraging professional growth. Follows-up routinely with feedback and encouragement.
- Works with senior management to find operational efficiencies in order to increase return on sales.
- Changes resource utilization accordingly to the demands of the project to ensure efficient personnel utilization with oversight.
- With guidance, interprets and acts upon project-specific financial reports.
- Considers financial implications of different decisions and operational strategies.
- Appropriately exhibits persuasive communication skills to enhance the likelihood of building commitment and buy-in.
- Establishes, builds, and fosters relations with influential decision makers both internal and external.
- Conveys difficult information diplomatically.
- Exhibits ability to adapt communication style and approach to circumstances, particularly when addressing concerns or proposing a solution.
- Actively participates on non-research project initiatives.
- Identifies and follows through on opportunities for self-improvement.
Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician’s Assistant (PA) or Pharmacist plus two 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) plus a minimum of five years healthcare experience; or
2. Completion of a master’s degree in Public Health, Health Administration or a related area with one year directly related clinical trials research experience; or
3. Completion of a bachelor’s degree plus a minimum of three years directly related experience in clinical trials research; or
4. Completion of a bachelor’s degree plus a minimum of four years closely related experience.
**State of North Carolina license may be required. **
None required beyond that described above.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
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Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.