Duke University CLINICAL RESEARCH SPECIALIST, SR in Durham, North Carolina


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Occupational Summary

Perform a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research, under the direction of a Clinical Research Coordinator or similar CRU/Oversight Organization designee.

Work Performed

Clinical research operations. – 40%

Identify participants that meet eligibility requirements under the supervision of a CRC (Allie Frear). Document in Redcap research database. Schedule participants for study visits for minimal risk studies 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. Maintain subject level documentation for minimal risk studies, or for other studies under direction. Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs. Assist with maintenance of study level documentation.

Facilitate completion of Patient Reported Outcomes surveys.

Collect, prepare, process, ship, and maintain inventory of research specimens for foundation-funded minimal risk, longitudinal, prospective observational cohort studies.

Ethical and participant safety considerations. 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.

Data management and informatics – 45%

Use Electronic Data Capture (EDC) systems (REDCAP), 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.

Assist in investigating incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data; follow SOPs for data quality assurance. Use required processes, policies, and systems to ensure data integrity, provenance, and security.

Leadership and professionalism. 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 – 5%

Prepare items for site initiation or monitoring visits with guidance from CRC. Participate in sponsor required training.

Communication and team science. 10%

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. Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively.

Perform other related duties incidental to the work described herein. The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Type of Research

This position will primarily be involved in federally and foundation-funded, multi-center, prospective research. The study population includes patients within the various stages of lung transplant, from both the pre-transplant evaluation and waitlisted phases to the post- lung transplant phase. Approximately 40% of the CRS, SR’s time will be spent organizing materials necessary for study visits, preparing for, collecting, and processing biological specimens, meeting with patients for minimal risk studies under the supervision of a CRC. Approximately 45% of the coordinator's time will be spent in data entry, quality control, query & resolution, IRB documentation, and study documentation. Study team members are cross-trained between studies among the lung transplant research team and collaborate in various study-related tasks, though some team members have assigned primary responsibilities to a specific study. Other responsibilities may include preparing agendas for team meetings, assisting with study team scientific presentations, and attending educational sessions or research presentations.

Special Skills

Given the nature of the research and the interaction that will take place with the patient population, the candidate should have some exposure to and familiarity with medical/clinical work and patient interaction whether through research or some other related field or occupation. The candidate must also be able to converse skillfully in a manner appropriate to working with patients, especially those with end-stage illness, and must be willing to work closely with team members and collaborate as a team. The candidate should be flexible and willing to assist other lab members as needed to complete projects, possess the ability to adapt to shifting priorities smoothly, possess excellent time management skills and attention to detail, and respond professionally to constructive scientific questioning and criticism.





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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).