Clinical Research 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 2,600 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. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

 

 

 

Clinical Research Coordinator [CRC]

Oncology Clinical Research Unit [CRU]

Brain Tumor CLINICAL [BTC]

 

Position Description, 

 

Occupational Summary

Provide leadership and coordination in the conduct of multiple, complex oncology clinical trials and research studies including Investigational Products [IP] for the Duke Cancer Institute’s [DCI] Cancer Population & Population Services Clinical Research Program [CCPS].  The Oncology Clinical Research Unit [CRU] oversees the conduct of research. 

Work Preformed

Operations, Study and Site Management – 40% Effort

Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, and SOPs. May train others in these policies and processes. Prepares for and provides support for study audit visits, including support for the reviewer. Prepares for DCI routine Monitoring Visits (DCI MV) and serve as point of contact for the DCI Monitoring Team (MT) and Safety Oversight Committee’s (SOC’s) expectations. Addresses and corrects findings.

 

Maintains participant level documentation for all assigned studies, and/or require access to the Duke EHR.

 

Follows SOPs and strategies to manage and retain research subjects. Recruits research participants according to study protocol. Screens participants for minimal risk studies.

 

Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Act as clinical liaison between Surgical, Biorepository and Clinical Research teams to coordinate tissue and biospecimen collection for IRB approved protocols within PRTBTC. Run reports to identify and prescreen eligible patients to be presented with a consent forms for tissue bank studies.

 

Build and maintain daily schedule to coordinate in-clinic or eConsent by data staff for the potential patients identified.

 

Track patients who consented across different platforms: Spreadsheets, Enrollment logs, REDCap or other platforms that may be established in future.

 

Maintains spreadsheets and Enrollment logs for biospecimen collected for tissue banking studies for current IRB approved protocols and future research.

 

Employ strategies to maintain recruitment and retention rates and assist participants with individual needs.  Collect information to determine appropriate study feasibility, recruitment and retention strategies.  Evaluate processes to identify issues related to recruitment and retention rates; offer solutions. 

 

Maintain study's compliance with institutional requirements and policies.  Maintain appropriate study-level documentation including regulatory binders, enrollment logs, and patient registration in th