CLINICAL TRIALS PROJECT LEADER II, 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 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

 

MIO Clinical Trials Project Leader II

 

Position Summary

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.

 

** 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, Indiana, Michigan, Maine, Ohio and New Hampshire.

 

 

Primary Responsibilities and Tasks

Independently 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

 

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.

 

Lead cross functional and sponsor facing research team meetings. Coordinate outside vendors and internal functional groups for potential projects including early trial budget negotiations and contract development.

Problem resolution and development of processes that improve project and institutional workflows.

 

Recommend guidelines and refinement of guidelines in the collection of clinical data and administration of clinical trials; assist in the determination of guidelines for new protocols

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 staff and research team and provide feedback to staff's supervisor on a routine basis; conduct cross functional research team meetings as needed. Participate in conjunction with the principal investigator in initial contacts with outside vendors and internal functional groups for potential projects including early trial budget negotiations and contract development. Perform other related duties incidental to the work described herein.

 

Other Duties

• Supervisory Responsibility:  Give work assignments to others; Review completeness and accuracy of the work of others; Give recommendations, advice, or guidance to others
• Financial Responsibility:  Develop budget recommendations; Prepare budget requests and written narrative; Review expenses against budget