Duke University · 1 month ago
CLINICAL RESEARCH COORDINATOR, SR
Durham, NC
Full-time
Onsite
Mid, Senior Level
4+ years expDuke University School of Medicine is a prestigious institution known for its commitment to health and research. They are seeking a Senior Clinical Research Coordinator to lead the NOTRE Study, which focuses on optimizing interventions for substance use and HIV prevention among justice-involved populations in the DC Metro Area.
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Responsibilities
Establishing Agreements: The hired candidate will work with the PI to identify when research-related agreements are required for their project (examples: independent contractor agreements, data use agreements, sub-award agreements, etc.)
Connecting with Appropriate Partners: The hired candidate will work with appropriate Duke offices, such as the Office of Research Contracts to establish contracts and agreements on behalf of the study team (example: data use agreements, sub-award contracts, etc.)
Regulatory Knowledge: The hired candidate will develop a deep knowledge of regulatory and institutional policies (examples: IRB submission, required enrollment reporting, etc.), serving as an expert for their team. They will provide appropriate training to their study team to ensure project compliance. They will also lead the development of SOPs for their project(s) and may have opportunities to provide recommendations and establish best practices across the lab
Regulatory Oversight: They will prepare the study site for monitoring and audit visits. They will also work with the study team to address and correct any concerns identified by reviewers
Participant-Level Documentation: The hired candidate will be responsible for maintaining all participant-level documentation (e.g., enrollment, survey and interview data) on all types of projects, including ones with complex research design. They will also train and supervise others
Participant Recruitment and Retention: The hired candidate will have expertise in all aspects of participant recruitment and retention. They will develop resources/tools for tracking, study enrollment and retention and will develop and implement strategies to create high levels of participant engagement. They will serve as an expert on their team, and will train and oversee others
Screening Participants: The hired candidate will be responsible for screening participants for eligibility and enrollment, including for projects with complex research design. They will create study-level documentation and SOPs. They will also provide enrollment training and resources for study staff across sites
Managing Human Specimens: The hired candidate will develop and maintain study-level documentation consistent with federal and institutional policies around human specimen collection (e.g., collecting, preparing, and processing specimens)
Participant Study Visits: The hired candidate will lead the research team(s) in the preparation and administration of participants for study visits (example: prepare documentation, equipment, supplies, establish participant payment infrastructure, etc.). They will also create study-level documentation and training materials to ensure consistency among staff
Leading Meetings: The hired candidate will take a leadership role in managing project meetings for the Duke site as well as larger, cross-site meetings. Responsibilities include identifying priorities, preparing and distributing agendas, running meetings, and creating and distributing minutes. They will also mentor their staff in communication best practices
Adverse Events: The hired candidate will monitor study activities for adverse events across projects. They will ensure timely reporting to the PI and required parties (e.g., IRB, Data and Safety Monitoring Board, Funders, etc.)
Participant Consent & Documentation: The hired candidate will develop participant consent materials for all types of studies, including those with complex research design. They will be responsible for developing SOPs and training staff on adequate consent processes and documentation
IRB Submission: The hired candidate will be responsible for developing and submitting IRB protocols, and mentoring/supervising other members of the research team in IRB protocol management
Regulatory and Safety Reporting: The hired candidate will prepare and submit regulatory and safety documentation to sponsors and other agencies
Data Entry: The hired candidate will collect and maintain study data and have knowledge of REDcap databases
SOP Development: The hired candidate will provide significant support in data analyses and management, including identifying/ recommending data capture methods for the research team
Supervision: The hired candidate will train research staff in data collection protocols and provide regular oversight over data quality and completeness
Quality Assurance: The hired candidate will provide routine data oversight and quality checks to ensure consistency with study protocols and federal and institutional requirements. They will serve as their research team’s expert on data management best practices
Data Analyses: The hired candidate will have the opportunity to work across the research team to develop protocols, strategies, and best practices around data security and provenance (e.g., data source, edits, and documentation). They will have the opportunity to make recommendations on process improvements across the lab relative to data management, security, and storage
Data Capturing: As appropriate, the hired candidate will develop and implement data capture methods, including using electronic case report forms (eCRFs) and Electronic Data Captures (EDC)
Trainings: The hired candidate will have the opportunity to seek out, integrate and apply trainings towards innovation and performance improvement for their research team
Data Visualization: The hired candidate will work closely with project leadership to develop data visualization to communicate study findings to diverse audiences
Grant Writing: The hired candidate will contribute meaningfully to the development of grant submissions and funding opportunities, including making recommendations for improving submissions
Literature Searches: The hired candidate will lead literature reviews to develop manuscripts or support grant developments
Protocol Development: The hired candidate will develop research protocols consistent with best research practices
Scholarly Product Development: The hired candidate will provide significant support to — or independently lead — the development of scholarly products, including leading presentations, creating academic posters, serving as an author on manuscripts, etc. The hired candidate will also contribute to the distribution of study findings to non-scientific audiences (example: blog posts, white papers, stakeholders, etc.)
Research Activity Management: The hired candidate will use Duke clinical research management system, like Oncore, to track/manage participant activities, such as enrollment, participant payment, interviews, appointments, etc
Participant Enrollment Reporting: The hired candidate will use Duke clinical research management system, like Oncore, to track and report participant enrollment data, maintain research protocols, and track and report on all research activities
Equipment and Supply Management: The hired candidate will be responsible for maintaining research materials, supplies, and equipment
Study Closeout: The hired candidate will work closely with the PI to prepare the study for closeout (example: consolidating materials, returning supplies, etc.)
Site Visits: The hired candidate will prepare for, coordinate, and actively participate in site visits. And will communicate effectively with sponsors
Professional Development: The hired candidate will have significant opportunity for professional development. They will work closely with their supervisor and PI to identify and facilitate training opportunities for themselves and other members of the study team
Continuing Education: The hired candidate will stay up to date with research best practices by attending talks, trainings, and workshops. They will also identify opportunities for members of their team to gain content expertise
Scientific-Community Engagement: The hired candidate will serve as a representative for the research team. They may also participate in committees or workgroups to disseminate study findings and research best practices
Interpersonal Skills: The hired candidate will work closely, and successfully, with individuals from diverse backgrounds
Conflict Management: The hired candidate will be aware of any organizational issues. If necessary, they will escalate them to the appropriate personnel
Communication Skills: The hired candidate will communicate effectively with others, regardless of reporting relationship, to accomplish shared work objectives. Establishes and assigns the activities of the research program team members to accomplish the study goals
Supervision: The hired candidate will provide formal and informal supervision to members of the research team by identifying opportunities and strategies for professional growth and ensuring that members of the research team are adequately performing key aspects of their work
Qualification
Required
An Associate's degree is required
Work requires a minimum of six years of research experience. A Bachelor's degree may substitute for 2 years required experience
Preferred
Previous experience coordinating a multi-site study
Previous experience working with criminal legal system-involved participants
Interest and experience in scholarly writing
Experience in research design and implementation science
Must live in Maryland or DC Metro Area
Benefits
Health insurance plans
Generous paid time off
Retirement programs with employer contributions
Tuition assistance for employees and their children
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
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