Senior Clinical Research Specialist, Duke Cancer Center

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.

Senior Clinical Research Specialist, Duke Cancer Center

 

Oncology Clinical Research Unit [CRU]

Bone Marrow Transplant, Hematology Malignancies & Cellular therapy Clinical Research Program [BMT]

 

Position Description, 

Occupational Summary

Perform a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research for the Duke Cancer Institute’s [DCI] BONE MARROW TRANSPLANT, HEMATOLOGY MALIGNANCIES & CELLULAR THERAPY CLINICAL RESEARCH PROGRAM [BMT] Clinical Research Program. Participate in day-to-day operations related to the collection, compilation, and documentation of clinical research data.  The Oncology Clinical Research Unit [CRU] oversees the conduct of research. 

Work Preformed

Operations, Study and Site Management – 60% Effort

Under supervision, assists with managing investigational products including arrival, storage, and handling (requisitions, inventory, and reordering). Under supervision, prepares for study monitoring and audit visits. Follows SOPs. Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Assists with maintenance of study level documentation. Prepares documents, equipment, supplies, etc. Assists with the conduct and documentation of non-complex visits and scripted testing or interviews.

Participates in study team meetings.

As directed, attends or schedules site visits. For studies with simple supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. Follows protocol-specific systems and process flows. As directed, assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor).

Communication – 20% of Effort

Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively. Respond to routine questions related to study protocol and refer more complex questions or escalate issues to others as appropriate. 

Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution. 

Data – 5% of Effort

Follows required processes, policies, and systems to ensure data security and provenance. Learns and uses new technology when required.

 

Leadership – 5% Effort

Maintains Duke and project specific training requirements. Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.). Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently. Demonstrates resilience and is adaptive to change. Communicates with other study personnel as required for study implementation and routine problem resolution.

Ethics – 10% of Effort

Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research.  Be familiar with the ethical conduct of research, and safeguards needed when conducting research with vulnerable populations.  Understand that the safety of research participants is a priority.  Identify and explain the risk and benefits for a clinical trial. 

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. 

Basic Life Saving [BLS] certification from the American Heart Association or Duke approved equivalent course is a requirement of this position. 

Under supervision may collect information about