CLINICAL RESEARCH COORDINATOR

Duke Careers•Durham, NC

4d•$59,829 - $99,960•Onsite

About The Position

The Bellwether Collaborative for Health Justice, part of the Duke University Department of Population Health Sciences, is seeking a Clinical Research Coordinator to co-lead all aspects of the CROSSROADS Study in Durham and Orange County, North Carolina. This study is an Implementation Effectiveness Trial comparing community paramedic standard of care to an intervention leveraging Medical-Legal Partnerships. The role involves managing research operations, ensuring regulatory compliance, overseeing participant documentation and enrollment, preparing for and administering study visits, and leading meetings. The position also requires attention to research ethics, including monitoring adverse events and managing participant consent. Data management responsibilities include data entry, SOP development, staff training, quality assurance, and adherence to data security protocols. The role will contribute to scientific endeavors such as grant writing, protocol development, and scholarly product development, including presentations, posters, and manuscripts, as well as disseminating findings to non-scientific audiences. Study and site management includes utilizing Duke clinical research management systems for tracking participant activities and enrollment, and managing research materials, supplies, and equipment. Leadership opportunities involve professional development, continuing education, scientific-community engagement, building respectful relationships with participants and stakeholders, and managing conflicts professionally.

Requirements

An Associate’s degree is required.
A minimum of two years of research experience is required.
Must live in the Durham/Orange County area.

Nice To Haves

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.
Experience with Duke clinical research management systems, like Oncore.

Responsibilities

Co-lead all aspects of the CROSSROADS Study in Durham and Orange County, North Carolina.
Establish research-related agreements such as independent contractor agreements, data use agreements, and sub-award contracts.
Maintain a working knowledge of regulatory and institutional policies, including IRB submission and enrollment reporting, ensuring team-wide compliance.
Prepare the study site for monitoring and audit visits and address concerns identified by reviewers.
Maintain participant-level documentation, track study enrollment and retention, and develop strategies for high participant engagement.
Screen participants for eligibility and enrollment, create study-level documentation and SOPs, and provide enrollment training for study staff.
Prepare and administer participant study visits, create study-level documentation and training materials for consistency across sites.
Take a leadership role in managing project meetings for the Duke site and cross-site meetings, including identifying priorities, preparing agendas, and distributing minutes.
Monitor study activities for adverse events and ensure timely reporting.
Develop participant consent materials in consultation with the Duke research team, develop SOPs, and train staff on consent processes and documentation.
Develop and submit IRB protocols.
Prepare and submit regulatory and safety documentation to sponsors and other agencies.
Collect and maintain study data.
Develop data management workflows and SOPs.
Train research staff in data collection protocols and provide oversight of data quality and completeness.
Ensure adherence to data security protocols and escalate data management issues.
Provide routine data oversight and quality checks.
Contribute to grant submissions and funding opportunities.
Work with the PI to develop research protocols.
Contribute to the development of scholarly products, including presentations, posters, and manuscripts.
Contribute to the distribution of study findings to non-scientific audiences.
Use Duke clinical research management systems (e.g., Oncore) to track and manage participant activities.
Use Duke clinical research management systems (e.g., Oncore) to track and report participant enrollment data.
Maintain research materials, supplies, and equipment.
Identify and facilitate training opportunities for professional development for self and study team members.
Stay up-to-date with research best practices by attending talks, trainings, and workshops.
Serve as a representative for the research team and participate in committees or workgroups.
Build respectful, collaborative relationships with participants, community partners, and institutional stakeholders using culturally responsive and trauma-informed approaches.
Recognize, navigate, and respond to interpersonal or organizational challenges with professionalism and sound judgment.