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 for a clinical team that conducts multiple, complex oncology clinical trials and research studies including Investigational Products [IP] for the Duke Cancer Institute's [DCI] GYN Clinical Research Program [GYN]. The Oncology Clinical Research Unit [CRU] oversees the conduct of research.
Operations, Study and Site Management- 20% Effort
Employ strategies to maintain recruitment and retention rates, and assist participants with individual needs. Oversee the collection of information used to evaluate study feasibility, recruitment and retention strategies. Evaluate processes to identify issues related to recruitment and retention rates; design solutions.
Work closely with the Principal Investigator [PI] and study team on recruitment and enrollment of study participants. Conduct and document consent for study participants.
Coordinate study activities for direct reports to successfully implement and conduct the study. Recognize and offer solutions to study problems. Escalate issues appropriately. Assist in the development of new studies. Oversee site initiation and closeout visits.
Oversee study compliance with institutional requirements, policies and appropriate study-level documentation such as regulatory binders, enrollment logs, and patient registration in the system of record. Ensure adverse events [AE] are recorded and reported appropriately. Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties.
Lead the development of Conflict of Interest [COI], Data Safety Monitoring Plans [DSMPs], and Research Data Security Plans [RDSPs]. Lead the coordination of external monitoring boards.
Oversee the procedures and documentation of study payment and participant care expenses. Monitor financial study milestones and report appropriately. Coordinate with financial teams and participate in budget development. Lead study budgets and closeouts.
Communication- 20% Effort
Serve as an expert resource on the conduct of research. Collaborate, and communicate with study personnel as required. Communicate concerns clearly in a professional manner. Respond timely to emails, phone calls and questions. Escalate issues to others as appropriate.
Data- 5% Effort
Detect issues related to data capture, collection or management and suggest solutions.
Oversee the required processes, policies, and systems to ensure data security and provenance. Recognize and report vulnerabilities related to security of physical and electronic data. Review data entry for accuracy and completeness; offer solutions to correct incomplete, inaccurate or missing data and documents to ensure accuracy and completeness of data.
Leadership- 25% Effort
Manage assigned staff including their day-to-day assignments, work schedule, work location, time off requests, and yearly evaluations.
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.
Serve as an expert resource for colleagues and teammates. Support colleagues in their project work; encourage completion.
Ethics- 10% Effort
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.
RN Responsibilities- 20% Effort
Operate within the scope of the professional capacity of a licensed RN as it relates to research. Provide direction and training to RN staff as needed .
Other work as assigned.
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
Work requires graduation from an accredited BSN or Associate's Degree in Nursing or Nursing Diploma program.
All registered nurses without a Bachelor's degree in Nursing [or higher] will be required to enroll in an appropriate BSN program within two years of their start date and to complete the program within five years of their start date.
Must have current or compact RN licensure in the state of North Carolina. BLS certification required.
Maintain compliance with required hospital and unit specific training competencies as well as an active RN status with the North Carolina Board of Nursing (NCBON).
Twelve months of appropriate clinical experience is required, plus four years of research experience.
Can easily use computing software and web-based applications [e.g., Microsoft Office products and internet browsers].
The preferred candidate will have oncology or research experience.
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.
As a world-class academic and health care system, Duke Health strives to transform medicine and health locally and globally through innovative scientific research, rapid translation of breakthrough discoveries, educating future clinical and scientific leaders, advocating and practicing evidence-based medicine to improve community health, and leading efforts to eliminate health inequalities.