Duke University · 1 day ago
Clinical Research Specialist, SR.
Durham, NC
Full-time
Onsite
Entry Level
1+ years expDuke University School of Medicine is a leading institution in medical education and research, dedicated to improving human health. They are seeking a Clinical Research Specialist, SR. to assist with managing research studies, including participant recruitment, data collection, and regulatory compliance under supervision.
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Responsibilities
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
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
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
Demonstrates a basic understanding of the elements of research study designs
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)
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
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
This role requires strong organizational, data management, and regulatory compliance skills to ensure all study activities align with institutional policies, and GCP standards
Qualification
Required
Work requires an Associate degree
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
Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers)
Company
Duke University
Duke University is a private research university providing undergraduate and postgraduate education in medicine and other disciplines.
10001+ employees
H1B Sponsorship
Duke University has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (274)
2024 (232)
2023 (202)
2022 (195)
2021 (148)
2020 (121)
Funding
Current Stage
Late StageTotal Funding
$71.15MKey Investors
North Carolina Biotechnology CenterUS Department of EnergyGlaucoma Research Foundation
2023-02-17Grant· $0.11M
2022-09-19Grant
2022-03-09Grant· $0.05M
Leadership Team
Barry Myers
Professor and Director
Dan Ariely
Professor
Recent News
2026-01-11
2025-12-18
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