Clinical Research Coordinator

Clinical Research Coordinator

Work Arrangement: Hybrid (On-Site and Remote mix) Location: Durham, NC, US, 27710 Personnel Area: MEDICAL CENTER

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 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

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 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: Overdose is one of the leading causes of death in the US. People who are exposed to or impacted by the criminal legal system disproportionately report using substances and experience high rates of overdose. Community Paramedic or Post-Overdose Response Team programs have grown across the country to address this crisis. These teams respond during and after overdoses to offer life-saving supportincluding naloxone, medications for opioid use disorder (MOUD), and connections to health and social services, to help people get care rather than face arrest or incarceration. However, these programs mostly focus on individual-level care. Research shows that broader issueslike lack of housing, difficulty accessing public benefits, and unmet legal needsalso drive overdose risk. These are sometimes called "health-harming legal needs" (HHLN). Medical-Legal Partnerships bring together legal and healthcare professionals to address these deeper challenges and reduce the chance of future overdose harm. The hired candidate will join our work on the CROSSROADS study, which is an Implementation Effectiveness Trial designed to compare the community paramedic standard of care to an intervention that leverages Medical-Legal Partnerships. The study is taking place at four sitesDurham and Orange Counties, NC; Portland, ME; Miami, FL; and Pittsburgh, PA. The hired position will join an existing team to co-lead research activities at the NC site, ensure timely completion of all regulatory activities, and provide administrative support to the academic partners at Brown University, the University of Miami, Boston Medical Center, and University of Pittsburgh.

Minimum Requirements: An Associate's degree is required. Work requires a minimum of two years of research experience. Special Skills: Previous experience supporting the work of multi-site or complex research studies; Experience or expressed interest in working with individuals impacted by the criminal legal system; Interest and experience in scholarly writing.

About the Position: The Bellwether Collaborative for Health Justice seeks a Clinical Research Coordinator to co-lead all aspects of the CROSSROADS Study in Durham and Orange County, North Carolina. The responsibilities of this position include the following:

Research Operations: Establishing Agreements: The hired candidate will work with the Lead Coordinator and PI to identify when research-related agreements are required for their project (examples: independent contractor agreements, data use agreements, sub-award contracts, etc.). Regulatory Knowledge: The hired candidate will have a working knowledge of regulatory and institutional policies (examples: IRB submission, required enrollment reporting, etc.) and ensure team-wide compliance and adherence to required policies. Regulatory Oversight: The hired candidate 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 participant-level documentation, tracking study enrollment and retention, and developing and implementing strategies to create high levels of participant engagement. Screening and Enrollment: The hired candidate will be responsible for screening participants for eligibility and enrollment. They will create study-level documentation and SOPs. They will also provide enrollment training and resources for study staff across all study sites. Participant Study Visits: The hired candidate will be responsible for the preparation and administration of study visits. They will create study-level documentation and training materials to ensure consistency among staff across all participating sites. 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. They will work closely with project leadership to facilitate team meetings, including identifying priorities, preparing and distributing agendas, and creating and distributing meeting minutes. Research Ethics Adverse Events: The hired candidate will monitor study activities for adverse events and ensure timely reporting to the Lead Coordinator, PI, and required parties. Participant Consent and Documentation: The hired candidate will develop participant consent materials in close consultation with the Duke research team. They will also 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. Regulatory and Safety Reporting: The hired candidate will prepare and submit regulatory and safety documentation to sponsors and other agencies. Data Management Data Entry: The hired candidate will collect and maintain study data. SOP Development: The hired candidate will develop data management workflows and SOPs for their study. Supervision: The hired candidate will train research staff in data collection protocols and provide regular oversight over data quality and completeness. They will ensure that all members of the study team adhere to data security protocols and will identify and escalate data management issues appropriately. Quality Assurance: The hired candidate will provide routine data oversight and quality checks to ensure consistency with study protocols and federal and institutional requirements. Scientific Contributions Grant Writing: The hired candidate will contribute meaningfully to the development of grant submissions and funding opportunities. Protocol Development: The hired candidate will work closely with the PI to develop research protocols consistent with best research practices. Scholarly Product Development : The hired candidate will contribute to 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.) Study and Site Management Research Activity Management: The hired candidate will use Duke clinical research management systems, like Oncore, to track and manage participant activities, such as enrollment, participant payment, interviews, appointments, etc. Participant Enrollment Reporting: The hired candidate will use Duke clinical research management systems, like Oncore, to track and report participant enrollment data, maintain research protocols, and track all research activities. Equipment and Supply Management: The hired candidate will be responsible for maintaining research materials, supplies, and equipment. Leadership: 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 build successful, respectful, collaborative relationships with participants, community partners, and institutional stakeholders (e.g., community-based organizations, healthcare providers, and criminal legal system partners), using culturally responsive and trauma-informed approaches. Conflict Management: The hired candidate will recognize, navigate, and respond to interpersonal or organizational challenges with professionalism and sound judgment. They will address concerns directly when appropriate and escalate issues through appropriate channels as needed.

Choose Duke. Join our award-winning team as identified by Forbes magazine as America's Best Large Employer 2024 and be part of an inclusive culture that values excellence, innovation, and discovery. As an organization, we have exciting opportunities to be forward-thinking leaders in our field. We want talented individuals to join us, examine our current operations, and create innovative solutions that will revolutionize and enhance the way we approach our work. Duke University is consistently ranked among the top universities worldwide and is renowned for its cutting-edge research across disciplines. Beyond the engaging work, you'll also benefit from 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. Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $59,829.00 to USD $99,960.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer. Your total compensation goes beyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs,