Duke University · 1 month ago
CLINICAL RESEARCH SPECIALIST, SR
Durham, NC
Full-time
Onsite
Mid, Senior Level
1+ years expDuke University School of Medicine is a top medical school committed to improving human health through research and collaboration. They are seeking a Senior Clinical Research Specialist to assist in managing investigational products, recruit research participants, and ensure compliance with study protocols.
EdTechEducationHigher EducationUniversities
Responsibilities
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
Under supervision, may document some participant-level information 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
Independently 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 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
Follows requirements for depositing data into an appropriate repository and meta-data specifications for data sharing
With guidance, locates and follows repository-specific requirements to submit study data for sharing
Follows requirements for use of data standards for developing research databases
Learns and uses new technology when required
Assists with merging multiple datasets, recoding variables, and resetting scoring scales under supervision
Under supervision, assists in preparing tables, data visualizations, and lay summaries to communicate study results to participants
Assists in updating and may develop reports on study progress for the PI and other study team members and collaborators
Under supervision, executes testing process after the completion of a build, or following any project changes or system upgrades
May conduct some testing and documentation for Part 11 projects
Assists with simple literature searches
Under guidance, develops elements of research protocols for simple studies (e.g., registries, survey studies)
Provides some contribution to scientific publications or presentations
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, ensures that there are ample supplies and that equipment is in good working order
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)
Works with the manager to understand areas of opportunity and develop a training plan
Takes training courses and applies the knowledge and skills
May also train others in the skills learned
Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.)
Communicates with other study personnel as required for study implementation and routine problem resolution
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
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
Company data provided by crunchbase