CLINICAL TRIALS PROJECT LEADER I, DCRI, Outcomes

OCCUPATIONAL SUMMARY: The DCRI Outcomes group shares the DCRI's mission to develop and share knowledge that improves the care of patients around the world through innovative clinical research. The Outcomes Project Leader I position provides leadership to the department and to population studies, pharmaco-epidemiology, quality improvement, and comparative-effectiveness research. The Outcomes Project Leader has knowledge of outcomes research, thought leadership, protocol development, study design, project leadership, survey design, site management, data collection and analysis, and medical writing/editing. Oversees assigned projects and is active in developing more efficient and effective research processes and strategies for observational data registries supported by the department. The Project Leader provides cross-functional coordination for all project activities and ensures seamless integration of teams across specialties for focused and informed decision-making. This includes coordination across Duke and with external organizations.

The Outcomes Project Leader I typically leads the operations on one or more research projects of average to moderate complexity, at times with oversight of a more senior (Outcomes) Project Leader. Additionally, the Project Leader I may work in tandem on a large and complex study with defined areas of responsibilities apart from a more senior Project Leader. This Project Leader will be a part of the PCORnet project management team and will engage with staff and colleagues inside and outside DCRI.

Travel is required.

** 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, New Hampshire, Alabama, Kentucky, Louisiana, Oregon, Iowa, Missouri, Delaware, and Connecticut, Rhode Island, Vermont and Wisconsin.

WORK PERFORMED

Stakeholder Engagement:

• Develop systems and processes to support value-driven, inclusive, person-centered engagement models for clinical research.
• Manage stakeholder groups incorporating lived experience into study processes and materials.
• Create cohesive and inclusive engagement strategies that foster collaboration, information sharing, and dissemination of findings.

Administrative Management:

• Includes supervisory responsibility for assigning work to others, reviewing completeness & accuracy of work of others, giving recommendations, advice, or guidance to others.
• Work as part of a close and collaborative team and manage assigned duties in collaboration with project team, supports and contributes to the administrative processes for the (Outcomes) group and overall department.

• Interact comfortably and professionally with high-level administrators in sponsor organizations and other external organizations as well as with peers at external institutions and internally.

• Holds responsibility for and provides technical, fiscal, and management oversight for assigned projects and tasks. Projects may be of moderate complexity or pieces of larger projects managed by a higher-level Project Manager.
• Provides service-oriented support to other functional sub-groups, departments and project teams.

Project Leadership:

• Provide leadership on behalf of the project and organization to ensure success of Duke's research endeavors.
• Work alongside Faculty to develop project objectives, methodology and operational solutions that will meet scientific and strategic goals.
• Responsible for assuring that timelines, costs and deliverables of (Outcomes) projects are well- managed. This will often require external relationships and managing subcontracts and change orders to existing contracts.
• Contribute to business development activities for (Outcomes) projects such as presentations to prospective sponsors, development of scope of work, contract assumptions and cost estimates.
• Consult with collaborating organizations and vendors on implementation of project requirements.
• Lead project reviews, capacity planning, communications, study meetings, and teleconferences.
• Capture experiences and lessons learned as routine part of project lifecycle.
• Manage internal and external customer expectations.
• Identify and ensure compliance with regulations and policies.

Technical:

• Consult on or provide direct support for complex research efforts with significant health services research components across the Duke community and collaborators.
• Identify and support the development, adoption and use of tools, templates and best practices across projects.
• Identify and produce resolution to common problems including appropriate people to ensure successful resolution and take steps to reduce potential for recurrence on this or other projects.

Training:

• Educate internal and external partners on the value and role provided by outcomes clinical research.
• Maintain working knowledge of health services research, cost-effectiveness research and innovative approaches to clinical research.
• Develop and conduct training sessions for internal and external staff; present at conferences and/or publish in peer-reviewed journals.
• Contribute to department training and development infrastructure.

Perform other related duties incidental to the work described herein.

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

REQUIRED QUALIFICATIONS AT THIS LEVEL

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 two years of healthcare experience; or one of the following equivalents:

1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiological 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 research experience.

** State of North Carolina license may be required**

Experience: None required beyond that described above.

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Skills:

• This position required excellent communication and teamwork skills acquired through participation on a project management team and/or with a national registry or research network.
• Must have demonstrated ability to identify and solve problems independently. The position requires attention to detail and strong ability to work in a self-directed manner and to balance multiple priorities.

Minimum Qualifications

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) or Associate's degree in Clinical Trials Research related curriculum 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 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

None required beyond that described above. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE