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,  Duke Cancer Institute (Hybrid)

Oncology Clinical Research Unit [CRU]

 BONE MARROW TRANSPLANT, HEMATOLOGY MALIGNANCIES & CELLULAR THERAPY CLINICAL RESEARCH PROGRAM [BMT]

Position Description, 04/2024

Occupational Summary

Perform a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research for the Duke Cancer Institute’s [DCI] BONE MARROW TRANSPLANT, HEMATOLOGY MALIGNANCIES & CELLULAR THERAPY CLINICAL RESEARCH PROGRAM [BMT] Clinical Research Program. Participate in day-to-day operations related to the collection, compilation, and documentation of clinical research data.  The Oncology Clinical Research Unit [CRU] oversees the conduct of research. 

Work Preformed

Operations, Study and Site Management – 10% Effort

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. 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. Employ strategies to maintain retention rates. Evaluate processes to identify problems with retention. May train or oversee others. Develops and oversees the implementation of strategies for meeting recruitment goals for the research program(s). Provides training. Develops, oversees adherence, and trains in the use and development of SOPs across multiple study teams/research program(s). Provides expertise to research program team members in study level documentation. Provides oversight and training and lends expertise to research program. 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.

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 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. 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 multiple study teams or sites.

Description of Portfolio Responsibilities – 68% of Effort
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.

Communication – 10% of Effort

Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively. Respond to routine questions related to study protocol and refer more complex questions or escalate issues to others as appropriate. 

Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution. 

Data – 2% of Effort

Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for multiple research teams/research program, as relevant

Leadership – 5% Effort

Proactively seeks opportunities to add relevant skills and certifications to own portfolio. 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 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.

Ethics – 5% of Effort

Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research.  Be familiar with the ethical conduct of research, and safeguards needed when conducting research with vulnerable populations.  Understand that the safety of research participants is a priority.  Identify and explain the risk and benefits for a clinical trial. 

Know and follow policies, standard operating procedures (SOPs), regulations and protocol requirements that govern clinical research.  Maintain Duke and project specific training and certification requirements. 

And other work as assigned. 

The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required.  Employees may be directed to perform job-related tasks other than those specifically presented in this description.

The intent of this job description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities. 

Preferences

Bachelor's Degree is strongly preferred.

Qualifications Required At This Level

Link to view the education, experience and skills required for the 803 Clinical Research Specialists, Senior classification: https://forms.hr.duke.edu/descriptions/university/select.php?ID=803

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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