RESEARCH PROGRAM LEADER

School of Medicine: Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe. Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Occupational Summary
Develop, coordinate, and implement research and administrative strategies essential to the successful management of research programs led by investigator(s) and faculty. Perform and/or oversee a variety of complex duties involved in the collection and evaluation of research program data to monitor progress toward program and project milestones. Provide guidance on portfolio/project implementation strategy to provide direction for research activities within the portfolio or program. Assist with efforts to obtain and manage study or program funding. Frequently interact with other research groups or programs, by serving as primary liaison and public relations lead for research program and related projects. Coordinate wider program activities with responsibility for results in terms of costs, methods, and reporting requirements.

Work Performed
Program, Project, and Portfolio Management (at least 50%).
In collaboration with the investigator(s), sets and defines measures for short- and long-term goals of the research program/shared resource.
Identifies gaps, constraints, needs, and milestones; helps develop operational sustainability plan and communicates with PI to plan necessary resourcing.
Manages and documents all aspects of research project lifecycle including initiation, planning, executing, monitoring, and closing.
Directs project staff in the execution of project activities in accordance with project plan and timeline.
Communicates project/program progress with all major stakeholders and adjust plans and timelines according to feedback.
Represents research program or shared resource on behalf of the PI at internal and external meetings.
Provides intellectual contribution to the research program or shared resource, including developing and editing research proposals and manuscripts.
Manages the research program or shared resource operations.
Monitors and adheres to the established budget and assists with budget development.
Ensures that institutional communications are shared with research program staff and faculty.
Maintains communication within program and with other departments or offices to accomplish the program objectives and an awareness of regulations, policies, and resources relevant to research and therapeutic area and applies knowledge to the development and execution of operational plan.
Manages, mentors, and/or trains staff.

50% or less should be encompassed by the duties/sections below:Research Operations.

Serves as an expert resource and may provide training to research program team members regarding, regulatory and institutional policies and processes, screening, recruitment, retention, study monitoring, audit visits, participant and study level documentation, study visits, SOPs, specimen management, IND/IDE documentation, investigational product, and contracts and agreements.

Safety and Ethics.

Provides oversight and training to research program team members who: develop and submit documentation and information for IRB review, prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies, identify and document adverse event information, conduct, document, and develop consent for participants for all types of studies.

Data.
Selects and implements data capture methods appropriate for the research program. Serves as an expert in and oversees the processes of designing ECRFs and EDCs, data flow, data corrections, queries, quality assurance, data security and provenance.

Recognizes trends and recommends strategies to improve processes or retrain staff.

Develops and implements protocols for research program that include strategies and processes to ensure data security, provenance, and data flow.

Seeks out, integrates, and app lies new technical knowledge towards innovation and performance improvement for research program, as relevant.

Scientific Concepts.
Independently writes and edits substantial portions of funding proposals and grants, develops protocols for multiple complex investigator- initiated studies within the research program, and synthesizes literature to assist in the development of manuscripts or grant proposals.

Uses expertise in research design to provide significant contribution to protocols or research proposals.

Site and Study Management.
Makes feasibility recommendations for research program.
Develops and oversees processes to determine participation in trials.
Works with the CRU or departmental leadership to ensure that studies within the research program are conducted in compliance with institutional requirements and policies
Mentors, trains, and oversees activities related to how teams communicate with sponsors and/or CROs, site visits, management of resources (staff, supplies, equipment) and implementation of operational plans across the research program; and use of systems and system reports.

Leadership and Professionalism.
Evaluates and implements professional development and/or training prog rams to ensure they meet the needs of staff retention, continuous improvement, and development.
Keep s current with advances in the scientific area and considers the impact on the research program.
Keeps self and team current with research updates by attending external offerings.
Uses advanced subject matter expertise to solve complex problems or foster innovation within the research program.
Plays a key leadership role on committees and workgroups.
Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently.
Develops and implements solutions that work within the existing leadership or organizational structure.
Demonstrates resilience and actively facilitates the research program through change.
Communicates effectively with others to accomplish shared work objectives.

Minimum Qualifications
Education
Completion of a Bachelor's degree

Experience
Work requires a minimum of four years of research experience (e.g., experience. research, clinical, interaction with study population, program coordination). A Master's degree may substitute for two years of related 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.