Clinical Trials Project Leader Iii, Dcri

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe.

Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Position Summary:

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 II's.

NOTE: This position may have an opportunity to work remotely.

All Duke University and Duke Health remote workers must reside in one of the following states or districts: Arizona; California; Florida; Georgia; Hawaii; Illinois; Maryland; Massachusetts; Montana; New Jersey; New York; North Carolina; Pennsylvania; South Carolina; Tennessee; Texas; Virginia or Washington, DC., Washington (State), Connecticut

Primary Responsibilities and Tasks:

1.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.

2.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.

3.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.

4.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.

5.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.

Required Education/Training:

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, and 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.

Minimum Qualifications

Education

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 Associate's 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.

Experience

None required beyond that described above. ORAN 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.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes.

To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

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.

Nearest Major Market: Durham

Nearest Secondary Market: Raleigh