Clinical Research Specialist, Senior

North Carolina, United States
29 Oct 2018
End of advertisement period
29 Dec 2018
Contract Type
Full Time

Job Description

Occupational Summary

Perform a variety of research, data, and clerical duties of a routineand technical nature to support the conduct of clinical research underthe supervision of a Clinical Research Coordinator or similarCRU/Oversight Organization designee. Participate in day-to-dayoperations related to the collection, compilation, and documentation ofclinical research data.


Screen participants for minimal risk studies.  May screen participants for studies with greater than minimal risk, under supervision. Maintain subject level documentation for all studies independently Schedule participants for study visits as directed. Prepare necessary documents, equipment, supplies, etc. Conduct and document visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments, and Standard Operating Procedures (SOPs) for minimal risk studies or for other studies under direction.  Follow procedures and documentation of study payment. Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks.  Collaborate to maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc. Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs. Conduct and document consent for participants in minimal risk studies. May conduct consent for studies with greater than minimal risk, under the supervision of a CRC or CRNC. Prepare for study monitoring and study audit visits. Collect, prepare or process adverse event information under supervision. Provide input for adverse event reports  Provide input for DUHS IRB documents such as consent forms, protocols, and continuing reviews.


Communicate to research participants, both orally and written, the difference between clinical activities and research activities in all study documents and research participant communications. 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 the explain the risk and benefits to a subject as these pertain to your clinical trial 


Map a protocol's data flow plan: data capture, storage, management, quality,  and preparation for analysis Use Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations with little assistance.  Enter data accurately.  Score tests and measures according to protocol, and appropriate to role. Complete paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol. Use required processes, policies, and systems to ensure data security and provenance. Assist in investigating incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Follow SOPs for data QA. Recognize when data agreements are necessary 


Encourage and support colleagues in completing project work. Assist research colleagues in identifying efficiencies and improving process. May serve as mentor to other staff. Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. Maintain Duke and project specific training requirements. 

Study and Site Management:

Assist with the development of protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms.


Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively. Participate in study team meetings. Respond to routine questions related to study protocol and refer more complex questions to others as appropriate.   Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution.

Preferred Qualifications:

Experience with bio-banking and/or specimen collection and handling is preferred but not required.  Strong computer skills for data acquisition and entry are required.  Excellent verbal and written communication is essential.

Requisition Number




Duke Entity


Job Code


Job Family Level




Full Time / Part Time


Regular / Temporary




Minimum Qualifications

Duke University 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 essential job 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.


Work requires an associates degree.


One year of relevant experience (e.g., research, clinical, interaction with study population, program coordination).

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