Research Program Leader, Duke Cancer Center

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.

Research Program Leader [RPL]

Oncology Clinical Research Unit [CRU]

gyn onc clinical research [GYN]

Position Description, 

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. Serves as an expert resource to multiple study teams/research program regarding regulatory and institutional policies and processes. Oversees the management and documentation of investigational products (IP) for multiple study teams/research program. Serves as an IP expert resource for study teams. Designs, implements, and optimizes methods for handling IP. Provides direction to multiple study teams/research program to prepare for study monitoring and audit visits. 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. Serves as an expert resource for multiple study teams/research program for participant retention. Liaises with other resources at Duke to optimize retention rates. Develops and oversees the implementation of strategies for meeting recruitment goals for the research program(s). Provides training. Serves as an expert to research program team members in the area of screening.  May provide oversight and conduct training in this area. 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. Serves as an expert resource and trainer to multiple study teams/research program for preparing and conducting complex study visits, developing tools, and implementing operational plans. 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.

Ethics:
Serves as an expert in AE identification and documentation, including liaising with and being knowledgeable about other resources at Duke. 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. Provides oversight and training to multiple study teams/research program team members who develop and submit documentation and information for IRB review. Provides oversight and training to multiple study teams/research program team members who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies.

Data:
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. Provide support for various tools used for analysis and data management. Enters and collects data.  Develops data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data. Manage and clean data in preparation for analysis under supervision. 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. Recognizes and reports security of physical and electronic data vulnerabilities. May develop or review data lifecycle and management plans for multiple study protocols. Works with the CRU or departmental leadership to ensure that data is shared according to best practices and guidelines. Under supervision, performs de-identification on allowable data to Safe Harbor standards. Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for multiple research teams/research program, as relevant. Under supervision, assists in preparing tables, data visualizations, and lay summaries to communicate study results to participants. 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. Under supervision, executes predetermined testing scripts after the completion of a build, or following any project changes or system upgrades.

Science:
Assists with or contributes to the development of funding proposals. May assist with simple literature searches under supervision from PI or CRC. Demonstrates and applies a basic understanding of open science practices and the FAIR data principals. Under guidance, develops elements of research protocols for simple studies (e.g., registries, survey studies). Demonstrates a basic understanding of the elements of research study designs. Provides some contribution to scientific publications or presentations (no authorship).

Study and Site Management:
Mentors, trains, and oversees activities related to how teams communicate with sponsors and/or CROs. Oversees activities related to site visits. Oversees use of systems and system reports to manage research participants' activities and tracking/marking financial milestones. Oversees use of systems and system reports to manage research protocol activities and maintaining current protocol information. Makes feasibility recommendations for multiple study teams/research program.  Develops and oversees processes to determine participation in trials. For studies with simple supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. For multiple study teams, ensures that studies are conducted in compliance with institutional requirements and other policies. Oversees implementation of operational plans across research program, including at multiple sites. Works with the CRU or departmental leadership to ensure that studies are closed according to best practices and guidelines.

Leadership:
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 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. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve complex problems or foster innovation across the broad research portfolio. 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.


Description of Portfolio Responsibilities: 
Determines short- and long-term goals of the research program/shared resource in collaboration with 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.

The position will lead the GYN ONC research program in the Duke Cancer Institute, including clinical research portfolio management and project implementation strategy within the GynOnc clinical research team.  The role will assist with the development of clinical study budgets, monitor the GynOnc clinical research hub and study finances as well as liaise with the study start-up team, ORC, ORA and other entities, including grants and contracts management to ensure the efficient working of the GynOnc study team and opening of GynOnc studies. The role will manage the GynOnc study team under the supervision and support of the GynOnc research practice manager.
The position will manage the GynOnc research program and portfolio, including monitoring the health of all clinical research studies within the program.
The role will be the direct supervisor/manager of up to 2 CRNCs, 2 Reg Coordinators, and 3 CRCs (when team is fully staffed). The GynOnc study portfolio includes a variety of ISTs, Foundation and federally funded/cooperative group studies at any given time.
The position may need to interface with external entities such as sponsors and funders, and internal entities such as ORC, ORA, RAZR and other disease groups or DCI locations (e.g., Wake County).

Description of Clinical Responsibilities:

Clinical responsibilities:


Type of Research:
The position will oversee the gynecologic oncology clinical research program, under the direction of the disease group lead, Dr. Angeles Secord, and the Research Practice Manager.  This person may step in to support clinical research staff as needed but is not expected to have an assigned patient/participant load. Rather, this person will direct the day-to-day activities of the research staff, identify new study opportunities and determine their feasibility in the DCI, oversee the development of operational plans for study execution, develop study budgets, review DOCR calendars and beacon builds with the study team, etc.

Special skills:
RN preferred but not required  Oncology research experience preferred  Clinical trial site budget development experience preferred  Project/program management experience preferred

Qualifications Required At This Level

Link to view the education, experience and skills required for the Research Program Leader, Senior classification: https://forms.hr.duke.edu/descriptions/university/select.php?ID=1280 

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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