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.
Occupational Summary
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] Breast Clinical Research Program [BRST]. The Oncology Clinical Research Unit [CRU] oversees the conduct of research.
Work Performed
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 – 10% 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
- Create a team culture that fosters open communication, motivates staff, and encourages creativity. Oversee the fair and consistent application of human resource policies. Collaborate closely with DCI Human Resources on personnel issues; policies, personnel file documentation and compliance.
- Lead, supervise and manage assigned staff – their day-to-day assignments, work schedule, work location, approve time off requests, conduct yearly evaluations, and actively engage in performance management including coaching, career development, training and corrective action. 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 measurable goals, monitor performance and quality of work. Assign staff duties and responsibilities; cross-train and reassign as needed. Foster and encourage the professional development of staff. Oversee staff training and certifications to ensure compliance with standard operating procedures [SOPs], regulations and processes.
- 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 – 15% 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.
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.
Education
Work requires graduation from an accredited BSN or Associates Degree in Nursing or Nursing Diploma program. All registered nurses without a Bachelors degree in Nursing (or higher) are encouraged to enroll in an appropriate BSN program within two years of their start date but must complete the program within seven years of their start date. Must have current or compact RN licensure in the state of North Carolina. BLS 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). Exception: Registered nurses hired before September 1, 2016 are not required to enroll in a BSN program to remain in this job classification.
Experience
Twelve months of appropriate clinical experience is required, plus four years of research experience.
Preferences
Previous oncology or research experience is preferred.
Job Code: 00001204 CLINICAL RESEARCH NURSE COORDINATOR, SR
Job Level: 55
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 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.
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Nearest Secondary Market: Raleigh
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