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 2,600 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.

Occupational Summary

Develop, coordinate, and implement research and administrative strategies essential to the successful design, management, and completion of research projects and other activities on clinical trial methodologies conducted by the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by the US Food and Drug Administration's (FDA's) Office of Critical Path Programs and Duke University; represent CTTI to internal and external audiences through presentations, discussions about project concepts and plans, and interactions with member and non-member organizations about CTTI activities.

** 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

Work Performed

• Conduct landscape assessments for project topics suggested by CTTI member organizations, the CTTI executive director, or the FDA. Utilize information from landscape assessments to develop project concept proposals for consideration by CTTI's Executive Committee.
• In collaboration with the CTTI Director of Projects, assist in the development of project plans for concepts approved by the Executive Committee.
• Develop task lists, list of skills needed in team members, and estimated human and financial resources needed for new project plans.
• Serve as an operational partner to CTTI project Team Leader(s) who will provide vision and context for the specific project; define realistic project timelines and milestones and as central person responsible for facilitating the activities of the project team composed of individuals from a variety of sectors, such as FDA, industry (drug, device, biologic, or CROs [clinical research organizations]), investigator groups, NIH, professional societies, and patient representatives.
• Coordinate and manage all aspects of selected CTTI projects as assigned, ensuring adherence to project timeline, budget, and deliverables.
• Maintain awareness of various stakeholder perspectives applicable to a project and identify strategies to engage multiple stakeholders in the project.
• Facilitate and guide communications/interactions among project team members, the CTTI Steering Committee, Executive Committee, and the Executive Director.
• Work with team members to submit protocols for IRB review, if applicable, and maintain currency of all regulatory requirements for all projects and assist in the writing/preparation of abstracts, manuscripts, and presentations related to specific projects.
• Prepare a variety of narrative and analytic reports, documents, and correspondence for CTTI leadership, team leader(s), and team members regarding project status; recommend corrective action as necessary.
• Develop and implement strategies for dissemination of project results and associated CTTI recommendations and represent CTTI by giving presentations about the organization and projects to internal and external audiences.
• Perform other related duties incidental to the work described herein.

Required Qualifications at this Level

Education/Training

Work requires analytical, communications, and organizational skills acquired through completion of bachelor's degree program within relevant health related disciplines and sciences.

Experience

Prefer knowledge of clinical trial operations. Experience working in healthcare, clinical research and/or a project-oriented organization preferred.

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Skills

Desirable Attributes

Professional demeanor

Skill in interacting with senior faculty and executives in industry and government

Ability to exercise discretion and judgment

Attention to detail

Political sensitivity

Ability to travel to all events and serve as on-site point of contact

Additional knowledge and skills

Budget preparations

Event planning

Negotiation

Strong communication skills (oral, written and listening)

Team skills

Software knowledge:

Microsoft Windows

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Asana

Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus three 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 six years healthcare experience; or 2. Completion of a master'sdegree in Public Health, Health Administration or a related area with two years directly related clinical trials research experience; or 3. Completion of a bachelor's degree plus a minimum of four years directly related experience in clinical trials research; or 4. Completion of a bachelor's degree plus a minimum of five years closely related research 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.

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.