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 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.

 

Pharmacometrics

 Clinical Trials Project Leader I

 

Position Summary 

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.

 

 

** 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

Project Management:

a) Develops, coordinates, and implements strategies and processes essential to the successful management of clinical research projects.

b) Contributes to protocol design and modification.

c) Defines and executes realistic project timelines and milestones from contract negotiations to close-out.

d) Develops and maintains project history, operations documentation, and files.

e) Exhibits ability to manage a heavy workload by prioritizing appropriately.

f) Exhibits operational understanding of scientific premise of study, regulatory requirements, contractual requirements, technical issues, standard operating procedures, and common research processes and guidelines, including designs, methods, and data.

 

Problem Resolution:

a) Actively promotes a timely resolution of all operational issues and problems and ensures that appropriate personnel are included in the discussion.

b) Considers impact of decisions on project timelines, quality, and costs.

c) Consults with other project leaders, and others as appropriate, on resolution to operational problems.

d) Recognizes issues that would put a project at risk and alerts senior management.

 

Team Management:

a) Through an understanding of strengths, weaknesses, and respective roles, builds successful, inclusive, working relationships with and among all project team members (including substudy personnel, sponsors, and subcontractors).

b) Establishes and communicates to project team members the criteria and/or processes necessary to achieve a high level of quality and service.

c) Delegates tasks and ensures team member understanding of responsibilities and timelines to ensure that current deliverables and critical issues are addressed.

d) Encourages participation and input from team members as appropriate.

e) Holds cross-functional team members accountable for assignments with assistance from operations manager.

f) Provides constructive feedback about employee strengths, initiative, and developmental needs to line managers when appropriate