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 tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Provide leadership in the development of research concepts and implementation of the science into research study protocols for the Duke Cancer Institute’s [DCI] Brain Tumor Center Clinical Research Program [BTC]. The Oncology Clinical Research Unit [CRU] oversees the conduct of research.
This position will assist faculty in translation of basic science concepts into Clinical Trials.
Position supports Principal Investigators and faculty for Neuro-Oncology [adult and pediatric], Brain Tumor Immunotherapy, and DCI Brain Metastasis Center.
Operations, Study and Disease Portfolio Management
Work closely with the Principal Investigator [PI] and investigative team on study feasibility and design, IIT protocol and Informed Consent development, and recruitment and retention strategies; evaluating and making appropriate recommendations. Evaluate and include cultural diversity and competency in study design and conduct. Assist in the development of protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms. Develop safety and security documents; such as research data storage plans [RDSP], conflict of interest [COI], and data safety management plans [DSMP].
Serve as an expert resource in study design to ensure inclusion of safeguards, protection of vulnerable populations and ethical conduct standards.
Regulatory responsibilities include guiding studies through the Institutional Review Board [IRB] committee and processes. This includes using the various tracking tools with proficiency such as, ONCORE and IRIS (Duke IRB).
Coordinate research core services to assist assigned teams as needed; such as Investigational Drug Service [IDS] and Biobank.
Be familiar with intellectual property rights, invention patents, and technologies. Understand regulations related to investigational products with sponsors and sponsor -investigators. Assist with managing and review agreements such as Material Transfer and the Investigational New Drug Applications.
Take part in site initiation and closeout visits for clinical trials. Prepare for closeout and document storage.
Conduct literature reviews independently. Collaborate with stakeholders [statistical, operational, etc.] to ensure adequate design, implementation and testing of study aims. Identify operational shortcomings of proposals and protocols; make recommendations for successful implementation for IITs.
Develop research proposals or protocols with little assistance. Summarize study results. Assist in manuscript writing. Participate in scientific presentations and publications.
Assist colleagues in identifying efficiencies and improving process. Serve as an expert resource for colleagues and teammates. Support colleagues in their project work; encourage completion. Actively seek out continuing education opportunities for career development.
Collaborate and communicate with PI, colleagues, and study personnel. Communicate concerns clearly in a professional manner. Respond timely to emails, phone calls and questions. Escalate issues as appropriate.
Model the DCI’s core value “Cancer Care as It Should Be” for staff. Create a team culture that fosters open communication, motivates staff, and encourages creativity. Seek out, listen to, accept and act on feedback. Establish regular communication methods and meetings with staff; collectively and individually. Be available to staff on a routine basis to provide leadership and mentoring.
Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research.
Articulate, to study staff and research participants, the pathophysiology or reasoning for an individual protocol's inclusion and exclusion criteria. Provide departmental-wide training in the ethical conduct of research.
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.
Other work as assigned.
Medical writing, basic concepts of research protocol design. Ability to manage a project and collaborate with diverse communities to move projects from concept to regulatory submission.
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.
Qualifications Required At This Level
- Completion of a Bachelor's degree plus a minimum of four years of research experience.
- Completion of a master degree plus a minimum of two years of research experience.
Can easily use computing software and web-based applications [e.g., Microsoft Office products and internet browsers].
Internal to Duke preferred.
Project management background
Prior academic medical center experience a +
The preferred candidate will have experience in research and medical writing.
Duke 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 essentialjob 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.