School of Medicine:

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10Oncology Clinical Research Unit [CRU]

Bone Marrow Transplant, Hematology Malignancies & Cellular Therapy

Clinical Research Programs [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 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

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

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

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

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

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.

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.

The intent of this job description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities.

Preferences

Bachelor's Degree is strongly preferred.

Qualifications Required At This Level

Education/Training

Work requires an associate degree.

Experience

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

Skills

Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).

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.

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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.