Clinical Research Specialist, Senior

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.

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 Programs.  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 – 10% Effort

• Screen participants, conduct and document consent for participants in minimal risk studies. Maintain subject level documentation.  Schedule participants for study visits.  Prepare necessary documents, equipment, supplies, and  interviews according to study protocol and Standard Operating Procedures [SOPs]. 

• Follow procedures and documentation of study payment.  Assist with maintenance of study level documentation.  Define source document. 

• Collect, prepare, process, ship, and maintain inventory of research specimens. 

Communication – 10% 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 – 65% of Effort

• Use Electronic Data Capture (EDC) systems, technologies, and software to accurately enter study data.  Complete paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol.  Run summaries and reports on existing data. 

• Follow SOPs for data QA.  Use required processes, policies, and systems to ensure data security and provenance.  Independently investigate incomplete, inaccurate or missing data and documents to ensure accuracy and completeness of data.

• Recognize and report vulnerabilities related to security of physical and electronic data. 

Leadership – 5% Effort

• Actively network.  Actively and proactively participate in team meetings, committees, task forces and ad hoc groups. 

• Encourage career development by actively seeking out continuing education opportunities.  Support colleagues in their project work; encourage completion. 

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. 

And other work as assigned. The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required.  Employees may be directed to perform job-related tasks other than those specifically presented in this description.

Minimum Requirements

Education

Work requires an Associate's degree. Bachelor's Degree is strongly preferred.

Experience

One year of relevant experience. A Bachelor's degree may substitute for required experience.

Job Code: 00000803 CLINICAL RESEARCH SPECIALIST, SR
Job Level: 09

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