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RESEARCH PROGRAM LEADER
Job Title: RESEARCH PROGRAM LEADER
Job Code: 1280
FLSA: E
Job Level: 58
Revised Date: 01/08/2024
Job Family: JF 05
Occupational Summary
Develops, coordinates, and implements research and administrative strategies essential to the successful management of research programs led by investigator(s) and faculty. Performs and oversees a variety of complex duties involved in the collection and evaluation of research program data to monitor progress toward program and project milestones. Provides guidance on portfolio and project implementation strategy to provide direction for research activities within the portfolio or program. Assists 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. Coordinates wider program activities with responsibility for results in terms of costs, methods, and reporting requirements.
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.).
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, IND and IDE documentation, regulatory and institutional policies and processes, investigational products, 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.
Assists junior staff to address FDA review or issues. Provides oversight and guidance to those preparing documents, annual reports, and amendments required by the FDA.
May independently navigate conversations with foreign agencies and study teams to develop or obtain the required documentation for compliance with international regulations. May assist others with ensuring regulatory compliance with international studies.
Oversees the management and documentation of investigational products (IP) for research program. Designs, implements, and optimizes methods for handling IP. Designs, implements, and optimizes methods for handling IP.
Develops and oversees the implementation of strategies for meeting recruitment goals for the research program. Liaises with other resources at Duke to optimize retention rates.
Prepares for and leads effective facilitation of research program meetings 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 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 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 and 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.
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.
Required Qualifications at this Level
Education/Training
Completion of a Bachelor's degree
Experience
Work requires a minimum of four years of research experience (e.g., research, clinical, interaction with study population, program coordination). A Master's degree may substitute for two years of related experience.
Skills
Can easily use computing software and web based applications (e.g., Microsoft Office products and the electronic medical record).
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University 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 essential job 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.
