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 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 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

The Division of Pediatric Transplant and Cellular Therapies (PTCT) is looking for an enthusiastic and talented Research Program Leader (RPL) who will help manage a robust clinical research portfolio, including a large multi-site project. We are looking for an experienced candidate with strengths in leadership, research coordination and project management to assist in managing a growing research portfolio. The RPL will work closely with the Assistant Research Practice Manager (ARPM) and Division Chief in managing the research portfolio and establishing growth targets.

While this employee will not directly manage staff, they will be an integral leader in our team and will provide input into staff assignment in managing the research portfolio. They will work very closely with PIs, the ARPM, and the Division Chief to accomplish long-term goals within PTCT.

For the large multi-site project, we are working with institutions external to Duke and this employee will manage the project and coordinate with personnel internal and external to Duke. The multi-site project will include up to twelve external sites. The RPL will often work with the many offices and institutional resources within Duke.

Description of Portfolio Responsibilities: (Effort 60%):

Determines short- and long-term goals of the research program/shared resource in collaboration with the Division Chief, ARPM, and investigator(s). Identifies research programs/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/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/or 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.). 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.

Position will collaborate with ARPM and provide impact and direct work of PTCT research team (2-3 staff). The RPL will serve as a delegate of the PI for a multi-site study providing project progress with all participating sites and adjust plans and timelines according to feedback.

Operations:

For complex scenarios, recognizes when agreements are necessary within the research program. Facilitates the process by coordinating with study teams and appropriate Duke offices. Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes. Maintains study level documentation for international studies. May develop resources and tools for management of international studies, and/or coordinate with other entities or offices. Is responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants. Serves as the primary liaison with sponsors, IDS, and other parties as necessary. Follows protocol schema for randomization and blinding/unblinding. Participates in or leads development of monitoring and audit training sessions and/or policies and guidelines for research program. Serves as an expert resource to address and correct findings. Provides oversight, training, and expertise to multiple study teams/research program regarding participant level documentation for all studies, including those that are complex

in nature (e.g., procedural and interventional studies) and/or require DUHS billing. Employs strategies to maintain retention rates. Evaluates processes to identify problems with retention. For multiple study teams, develops and oversees the implementation of strategies for meeting recruitment goals. Provides training. Screens participants for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Provides oversight and training in screening activities to multiple study teams. Develops, oversees adherence, and trains in the use and development of SOPs across research portfolio. May provide input for institutional SOPs. Creates, optimizes, and oversees the systems for managing specimens for multiple study teams/research program. Serves as an expert resource and trainer in specimen collection, processing, preparation, shipping and maintenance. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Provides oversight and training and lends expertise to multiple study teams. Conducts and plans for complex study visits. Prepares for and leads research program meetings. Ensures good communication within the research program, including mentoring staff to improve communication strategies.

Ethics:

Ensures that multiple study teams/research program team members are appropriately identifying and documenting adverse event information. Provides oversight and training to multiple study teams/research program team members who conduct and document consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care. May serve as an expert resource with regard to conducting and documenting consent including liaising with and being knowledgeable about other resources at Duke. Provides oversight and training to multiple study teams/research program team members who develop the consent plan and document. Serves as an expert resource with regard to developing consent plans and documents for participants in a variety of studies. Develops and submits documentation and information for IRB review. Communicates with the IRB staff and reviewers and handles issues appropriately. May train or oversee others. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others.

Data:

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 multiple study teams/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. Develops and implements protocols for research program that include strategies and processes to ensure data security and provenance. Serves as an expert data provenance and security resource, including liaising with and being knowledgeable about other related resources at Duke. Serves as an expert resource to multiple study teams/research program with regard to mapping data flow. Predicts areas of vulnerability in the data flow plan. Determines areas where data provenance may be compromised, and helps study teams/research program staff work through solutions. Ensures that study teams are familiar with data flow resources at Duke. Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for multiple research teams/research program, as relevant.

Science:

Independently develops substantial portions of funding proposals and grants. Assesses and determines solutions for operational shortcomings of proposals. 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 publication or conference presentation. Mentors others in this area.

Study and Site Management:

Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs. Oversees use of systems and system reports to manage research participants' activities and tracking/marking financial milestones. Uses clinical research management system and its reports to manage all protocol activities, including minimum footprint, SIP counsel, and all aspects of maintaining current protocol information. May train others. Makes feasibility recommendations for multiple study teams/research program. Develops and oversees processes to determine participation in trials. Oversees management of resources (staff, supplies, equipment) for multiple study teams/research program. 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

institutional requirements and policies. Oversees implementation of operational plans across research program, including at multiple sites. Develops and implements closeout procedures for multiple studies across multiple teams.

Leadership:

Encourages staff to take part in professional development opportunities. Provides opportunities for staff to attend key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.). Plays key 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, leadership, and actively facilitates change for research portfolio. 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 activities of other managers to accomplish goals of the broad research portfolio.

Type of Research:

The position will oversee and manage a multi-site study and program of research. The complexity will vary and include studies that are complex in nature. The position will assign team personnel based upon project/program needs in coordination with ARPM

Special skills:

Prior clinical research experience required.

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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