Senior Clinical Research Nurse Coordinator, Duke Cancer Institute

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 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

 

Clinical Research Nurse Coordinator Sr. [CRNC Sr]

Oncology Clinical Research Unit [CRU]

bone marrow transplant, hematology malignancies & cellular therapy Clinical Research Program [bmt]

Position Description, 

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] Bone Marrow Transplant, Hematology Malignancies & Cellular Therapy Clinical Research Program [BMT].  The Oncology Clinical Research Unit [CRU] oversees the conduct of research. 

Work Preformed

Operations, Study and Site Management – 15% 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 – 30% 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