CLINICAL RESEARCH COORDINATOR, SR

Duke Careers•Durham, NC

35d•Remote

About The Position

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.Be You. The Bellwether Collaborative for Health Justice seeks a Senior Clinical Research Coordinator to lead all aspects of the NOTRE Study in the DC Metro Area. The study is a patient preference trial designed to optimize and test the efficacy of a co-packaged intervention LAI PrEP and buprenorphine (XR-B) intervention in the mid-Atlantic region of the country (Maryland and DC). This project is funded by the National Institute of Drug Abuse (NIDA) and a part of a national network entitled: The Collaborative Network to End the HIV Epidemic and Address Addiction in the Criminal Justice System (CONNECT). NIDA launched the Collaborative Network to End the HIV Epidemic and Address Addiction in the Criminal Justice System (CONNECT) in 2024 to address significant service delivery gaps at all points of the SUD and HIV care cascades for justice-involved populations. Our academic partners in this work include Friends Research Institute, Brown University, and the University of Arkansas for Medical Sciences. About the Bellwether Collaborative for Health Justice: As part of the Duke University Department of Population Health Sciences, it is the mission of the Bellwether Collaborative for Health Justice to shine a light on how the criminal legal system acts as a structural determinant of health and impacts population and individual level health outcomes. We are an interdisciplinary research team, led by Dr. Lauren Brinkley-Rubinstein. Our work draws on the expertise of criminal legal system-involved persons and carceral and community stakeholders to inform innovative research that has practice and policy implications. About the Research: Co-occurring substance use and HIV risk among people in carceral settings are a syndemic. Approximately 17% of all incarcerated people have an opioid use disorder (OUD), and the prevalence of HIV is 3-5 times that of the general population. Evidence-based interventions, such as pre-exposure prophylaxis (PrEP) and medications for opioid use disorder (MOUD, e.g., buprenorphine) can mitigate adverse OUD outcomes and prevent HIV infection, yet these interventions are underused in both carceral settings and during community re-entry. Even when they are put into practice, barriers to optimal uptake, adherence, and continuation often occur. Long-acting injectable (LAI) formulations of both PrEP and buprenorphine have recently been approved by the FDA, providing opportunities to innovate on how these medications are deployed. In addition, evidence in the community proves that integrated MOUD and HIV efforts, when delivered in tandem, improve outcomes for those with OUD, and that retention in MOUD predicts positive HIV prevention outcomes.

Requirements

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.

Nice To Haves

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

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.

Benefits

Duke's competitive benefits package including health insurance plans, generous paid time off, retirement programs with employer contributions, tuition assistance for employees and their children, and more.

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