CLINICAL RESEARCH SPECIALIST, SR
School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Perform a va riety of research, data, and clerical duties ofa routine and technical n ature to support the conduct of clinical research forthe Duke Cancer Ins titute’s [DCI] Bone Marrow Transplant, HematologyMalignancies & Cell ular Therapy Clinical Research Programs [BMT]. Participatein day-to-day operations related to the collection, compilation, anddocumentation of c linical research data. The Oncology Clinical Research Unit [CRU] oversees the conduct of research.
Operations, Study andSite Management – 10% Effort
Screen p articipants, conduct and document consent for participants inminimal ris k studies. Maintain subject level documentation.Schedule participants for study visits. Prepare necessary documents , equipment,supplies, and interviews according tostudy protocol and Standard Operating Procedures [SOPs].
Follow procedures and documentation of study payment. < /span>Assist with maintenance of study leveldocumentation.Define sourcedocument.
Collect, prepa re, process, ship, and maintain inventory of researchspecimens. < /span>
Communication – 10% of Effort< /p>
Write and speak clearly in a variety of settings and stylesto convey messagesand ideas effectively. Respond to routine questions re lated to study protocol andrefer more complex questions or escalate issu es to others as appropriate.
Communica te and coordinate with other study personnel as required forstudy implem entation and routine problem resolution.
Data– 65% of Effort
Use Electronic Data C apture (EDC) systems, technologies, and software toaccurately enter stud y data.Completepaper and electronic Case Report Forms (CR Fs and eCRFs) accurately andaccording to protocol. Run sum maries andreports on existing data.
Fo llow SOPs for data QA.Use requiredprocesses, policies, an d systems to ensure data security and provenance. Independ ently investigate incomplete, inaccurateor missing data and documents to ensure accuracy and completeness of data.
Recognize and report vulnerabilities related to security of physical andelectroni c data.
Leadership – 5% Effort
Actively network.Actively and proact ively participate in teammeetings, committees, task forces and ad hoc gr oups.
Encourage careerdevelopment by a ctively seeking out continuing education opportunities.Su pport colleagues in their project work;encourage completion.
Ethics– 10% of Effort
Recognize and employ the professional guidelines and code of ethicsrela ted to the conduct of clinical research. Be familiar with the ethical conduct ofresearch, and safeguards needed when conducting re search with vulnerablepopulations. Understand that the saf etyof research participants is a priority. Identify and exp lain 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 trainingand certificatio n requirements.
Basic Life Saving [BLS ] certification from the American Heart Associationor Duke approved equi valent course is a requirement of this position. p>
And other work asassigned.