Clinical Research Specialist, SR.

Clinical Research Specialist, SR.

Work Arrangement: On-Site Requisition Number: 263953 Regular or Temporary: Regular Location:

Durham, NC, US, 27710

Personnel Area: MEDICAL CENTER Date: Feb 27, 2026 School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Operations:

Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes. Under supervision, assists with managing investigational products (IP), including arrival, storage, and handling (requisitions, inventory, and reordering). Under supervision, prepares for study monitoring and audit visits. Maintains participant-level documentation for non-complex (e.g., questionnaire, data registry, scripted) studies outside of the EHR. Follows SOPs and strategies to manage and retain research participants. Recruits research participants according to study protocol. Screens participants in person or over the phone for non-complex studies (e.g., questionnaire, data registry, scripted) or may collect information from the EHR to assist study team in determining eligibility. Follows SOPs. Under supervision, employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Assists with establishing and maintaining study-level documentation. Schedules participants for research visits (excluding those requiring EHR access). Prepares necessary documents, equipment, supplies, etc., in compliance with the protocol. Conducts and documents non-complex visits and scripted testing or interviews. May manage participant payment. Participates in study team meetings.

Ethics:

Recognizes known potential adverse events, identified in the protocol or investigator brochure, and reports to the study team. Conducts and documents consent for participants in non-complex studies or minimal risk studies as defined by the IRB. These studies may include protocols with blood draws, repositories, survey studies, simple observational studies, and studies that do not involve investigational products or devices. Not permitted to tee up orders for second signature in Maestro Care. Assists with the development of consent plans and documents for participants. Under supervision, for non-complex studies (e.g., survey studies and registries), develops and submits documentation and information for IRB review.

Data:

Enters and collects basic data for research studies. May score scripted or validated tests and measures. Independently corrects and documents incomplete, inaccurate or missing data for non-complex studies. Follows SOPs for quality assurance. Runs summaries and reports on existing data. Follows required processes, policies, and systems to ensure data security and provenance. In addition, recognizes and reports security of physical and electronic data vulnerabilities. Learns and uses new technology when required. Assists in updating reports on study progress for the PI and other study team members and collaborators.

Science:

Demonstrates a basic understanding of the elements of research study designs.

Study and Site Management:
As directed, attends or schedules site visits. Records participant accrual information and consent documentation for non-complex studies in clinical research management system. Records basic protocol information in clinical research management system. For studies with simple supplies or equipment, assists with ensuring that there are ample supplies and that equipment is in good working order. Ensure that studies are conducted in compliance with institutional requirements and other policies. Follows protocol-specific systems and process flows. As directed, assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor).

Leadership:
Maintains Duke and project specific training requirements. Keeps current with research updates by attending key external departmental meetings (i.e., Research Wednesday, RPN, additional training, etc.). Demonstrates resilience and is adaptive to change. Communicates with other study personnel as required for study implementation and routine problem resolution.

Type of Research:
Will be involved in research that may include both retrospective and prospective components. Study populations vary depending on the project working primarily with adult patients seen within Duke University Health System or its affiliates. Research may involve chart reviews, surveys, interviews, or longitudinal follow-up of participants.

Special skills:
This role requires strong organizational, data management, and regulatory compliance skills to ensure all study activities align with institutional policies, and GCP standards.

This position is an entry-level position

Required Qualifications at this Level

Education/Training

Work requires an Associate degree.

Experience

One year of relevant experience. Completion of the DOCR North Carolina state approved Clinical Research Pre-Apprenticeship program may substitute for one year of required experience.

Skills

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

The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunities 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.

Duke is an 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 (including pregnancy and pregnancy related conditions), sexual orientation or military 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.

Nearest Major Market: Durham
Nearest Secondary Market: Raleigh