Research Program Leader
Provide leadership in the development of research concepts and implementation of the concept 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.
Position supports Principal Investigators for Neuro-Oncology [adult and pediatric], Brain Tumor Immunotherapy, and Brain Mets.
Operations, Study and Site Management
Work closely with the Principal Investigator [PI] and investigative team on study feasibility and design, protocols, and recruitment and retention strategies; evaluating and making appropriate recommendations. Evaluate and include cultural diversity and competency in study design and conduct. Assist with 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].
Responsible guiding studies through the Institutional Review Board [IRB] process including documents and communication.
Coordinate core services; 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. Manage agreements; such as Material Transfer and Investigational New Drug Applications.
Take part in site initiation and closeout visits. 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.
Develop research proposals or protocols with little assistance. Summarize study results. Assist in manuscript writing. Participate in scientific presentations and publications.
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.
Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. 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.
Supervise staff. 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.
Provide staff with clear measureable goals, monitor performance and quality of work. Assign staff duties and responsibilities; cross-train and reassign as needed to effectively conduct clinical research. Foster and encourage the professional development of staff. Oversee staff training and certifications to ensure compliance with standard operating procedures [SOPs], regulations and protocol requirements that govern 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. Serve as an expert resource in study design to ensure inclusion of safeguards, protection of vulnerable populations and ethical conduct standards.
Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical 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.
Duke Entity MEDICAL CENTER
Job Family Level 68
Full Time / Part Time FULL TIME
Regular / Temporary Regular
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.
- Completion of a bachelor's degree plus a minimum of four years of research experience.
- Completion of a master's degree plus a minimum of two years of research experience.
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.
Can easily use computing software and web-based applications [e.g., Microsoft Office products and internet browsers].
The preferred candidate will have experience in research and medical writing.