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.

Occupational Summary

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.Participate in da y-to-day operations relatedto the collection, compilation, and documenta tion of clinical research data.TheOncology Clinical Research Unit [CRU] oversees the conduct of research.</s pan>

Work Preformed

Operations, Study and Site Management – 10% Effort

Screen participants, conduct and document consent for participants i nminimal risk studies. Maintain subject level documentation. </sp an>Schedule participants for study visits. Prepare necessa ry documents, equipment,supplies, and interviews according tostudy protocol and Standard Operating Procedures [SOPs]. </spa n>

Follow procedures and documentation of study payme nt. Assist with maintenance of study leveldocumentation. Define sourcedocument.

Co llect, prepare, process, ship, and maintain inventory of researchspecime ns.

Communication– 10% of Effort</ span>

Write and speak clearly in a variety of settings and styles to conveymessages and ideas effectively. Respond to routine q uestions related to studyprotocol and refer more complex questions or es calate issues to others asappropriate.

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

Data – 65% of Effort

Use Electr onic Data Capture (EDC) systems, technologies, and software toaccurately enter study data.Completepaper and electronic Case Repor t Forms (CRFs and eCRFs) accurately andaccording to protocol. </s pan>Run summaries andreports on existing data.

Follow SOPs for data QA.Userequired processes, p olicies, and systems to ensure data security andprovenance. </spa n>Independently investigateincomplete, inaccurate or missing data and do cuments to ensure accuracy andcompleteness of data.

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

Leadership – 5% E ffort

Actively network.Actively a nd proactively participate in teammeetings, committees, task forces and ad hoc groups.

Encourage careerdevelop ment by actively seeking out continuing education opportunities.Support colleaguesin their project work;encourage completion.

Ethics – 10% of Effort</ p>

Recognize and employ the professional guidelines and code of ethicsrelated to the conduct of clinical research. Be famil iar with the ethical conduct of research, and safeguards neededwhen cond ucting research with vulnerable populations. Understand th at the safety of researchparticipants is a priority.Ident ify andexplain the risk and benefits for a clinical trial.

Know and follow policies, standard operating proced ures (SOPs),regulations and protocol requirements that govern clinical r esearch.Maintain Duke and project specific trainingand ce rtification requirements.

Basic Life S aving [BLS] certification from the American Heart Associationor Duke app roved equivalent course is a requirement of this position. </span >

And other work asassigned.</span >

Work requires an Associate's degree.

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

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.