Research Program Leader - Center for Aging

This position is grant funded

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:

The Research Program Leader (RPL) will develop, coordinate, and implement research and administrative strategies essential to the successful management of research programs led by investigator(s) and faculty at the Duke Center for the Study of Aging and Human Development. The RPL will join a growing research team working on studies led by investigators at the Duke Center for the Study of Aging and Human Development. The RPL will join the team of Dr. Robert Turner II, who leads the Black Men's Brain Health (BMBH) Project, which is dedicated to: 1) increasing the engagement of Black/African American men in cognitive aging and dementia research; 2) cultivating a diverse, culturally competent workforce to work with underrepresented populations (URPs); and 3) investigating ethnocultural disparities in dementia.

The RPL will perform and oversee program team members in 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 and 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 interacts 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.

Preferred Qualifications and Skills:

• The applicant should have excellent interpersonal and communication skills (both written and verbal), strong attention to detail, the flexibility to work both independently and collaboratively, and should understand critical aspects of project management including enrollment, retention, community outreach, regulatory compliance, data management, staff supervision, and coordination across studies. 
• At least two years of direct research project management experience and at least one year of employee supervision experience strongly preferred.
• Experience in public health, medical and health sciences
• Outstanding organizational, project management, critical thinking skills and problem-solving skills, with ability to collaborate with others
• Strong understanding of translational health and medical science research, including managing data sets preferred.
• Ability to manage multiple projects simultaneously and deliver consistently high-quality outputs on time
• Ability to exercise independent judgment, with demonstrated ability to set priorities and goals with adherence to project timelines required
• Evidence of strong operational skills with attention to detail is essential, as is the ability to move easily from the details to the big picture and back
• Prior experience with community engagement and diverse populations is a plus, as is experience being part of an academic clinical research group.
• Qualified candidates must be able to effectively communicate with all levels of the organization and with program partners outside of the institution
• We strongly encourage applications from candidates who foster and promote the values of cultural competence, diversity, inclusion, and equity.

Work Performed:

Program, Project, and Portfolio Management

• Determines short- and long-term goals of the research program and shared resource in collaboration with investigator(s). Identifies research programs and shared resources 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 and program progress with all major stakeholders and adjust plans and timelines according to feedback.
• 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.
• Manages, mentors, and trains staff. Maintains an awareness of regulations, policies, and resources relevant to research and therapeutic area and applies knowledge to the development and execution of operational plan. Ensures that all programs and projects are compliant with all relevant regulations and policies. Provides guidance to staff on best practices in research study or program conduct (e.g., recruitment, consenting, study documentation, program evaluation, data capture, etc.).
• Works with team leads to create job descriptions; work with Duke University HR to post open positions and triage incoming applications; coordinate and conduct candidate interviews.
• Exercises supervisory authority, including hiring, transferring, suspending, promoting, managing conduct and performance, discharging, assigning, rewarding, disciplining, and/or approving hours worked of multiple employees.
• Facilitates the development and deployment of educational and training materials for project teams members
• Provides intellectual contribution to the research program or shared resource, including developing and editing research proposals and manuscripts. Represents research program or shared resource on behalf of the PI at internal and external meetings.

Research Operations

• Serves as an expert resource and may provide training to research program team members regarding contracts and agreements, regulatory and institutional policies and processes, study monitoring, audit visits, participant and study level documentation, participant retention, recruitment, screening, SOPs, specimen management, study visits, and team meetings.
• For complex scenarios, recognizes when agreements are necessary within the research program. Facilitates the process by coordinating with study teams and appropriate Duke offices.
• Develops and oversees the implementation of strategies for meeting recruitment goals for the research program. Liaises with other resources at Duke as well as community partners to optimize recruitment and retention rates.
• Prepares for and leads effective facilitation of research program meetings across projects and institutions in order to achieve objectives. Ensures good communication within the research program, including mentoring staff to improve communication strategies.

Safety and Ethics

• Serves as an expert resource and may provide 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

• Serves as an expert resource and may provide training to research program team members regarding ECRF and EDC design, data management and cleaning, data security and provenance, data standards, data flow, and return of results.
• Under direct supervision from Biostatistician and PI may perform analyses on a variety of data formats and create data analysis plans. Prepares a wide variety of data formats for analysis. Provides support for various tools used for analysis and data management.
• Selects and implements data capture methods appropriate for the research program. Serves as an expert in designing ECRFs and EDCs to collect data according to protocols and research program processes.
• Oversees the process of QA, data corrections, and queries used within the research program, including creating and using QA protocols, queries, summaries and reports. Recognizes trends and recommends strategies to improve processes or retrain staff. Serves as an expert data corrections, queries, and quality assurance resource, including liaising with and being knowledgeable about other related resources at Duke.
• Works with the CRU or departmental leadership to ensure that data is shared according to best practices and guidelines.
• Predicts areas of data flow vulnerability. Determines areas where data provenance may be compromised, and helps staff work through solutions. Ensures that staff are familiar with data flow resources at Duke.
• Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for research program, as relevant.
• Develops reports on research program progress for the PI and other study team members and collaborators. Creates clear visualizations to help communicate key information to stakeholders.

Scientific Concepts

• Independently develops substantial portions of funding proposals and grants. Assesses and determines solutions for operational shortcomings of proposals.
• Independently reviews articles, synthesizes the literature, and uses them to assist in the development of manuscripts or grant proposals.
• Provides guidance around FAIR data and open science implementation Independently develops protocols for multiple complex investigator- initiated studies within the research program.
• Uses expertise in research design to provide significant contribution to protocols or research proposals.
• Provides significant contribution or leadership on accepted, peer- reviewed publications or conference presentations. Mentors others in this area.

Site and Study Management

• Mentors, trains, and oversees activities related to how teams communicate with sponsors and 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 to manage research participants activities and tracking and marking financial milestones as well as manage research protocol activities and maintain current protocol information.
• Makes feasibility recommendations for research program. Develops and oversees processes to determine participation in trials. May manage the budget for research studies.
• Works with the CRU or departmental leadership to ensure that studies within the research program are conducted in compliance with and closed according to institutional requirements and policies.

Leadership and Professionalism

• Evaluates and implements the department, CRU, or division professional development and or training programs to ensure they meet the needs of staff retention, continuous improvement, and development.
• Keeps 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; applies learned material on the job. Plays a key leadership role on committees and workgroups.
• Navigates processes and people involved in Duke clinical research as well as with outside partners, 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.
• Uses advanced subject matter expertise in the therapeutic area or clinical research to solve complex problems or foster innovation within the research program.
• Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives. Establishes and assigns the activities of the research program team members to accomplish the study goals.

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

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