Clinical Research Coordinator IIReports to: Jessica Shier, Research Program Leader, Sr.
What You'll DoClinical Research Operations- Coordinate and manage complex clinical research studies, including procedural and interventional protocols.
- Recruit, screen, consent, enroll, and retain research participants while ensuring compliance with protocol requirements.
- Manage participant scheduling, study visits, randomization activities, and protocol adherence.
- Maintain participant-level and study-level documentation for complex clinical research studies.
- Oversee investigational product (IP) receipt, storage, accountability, tracking, and dispensing activities.
- Prepare studies for monitoring visits, audits, site visits, and closeout activities, addressing findings and implementing corrective actions as needed.
- Serve as a primary liaison between sponsors, CROs, Investigational Drug Services (IDS), principal investigators, and other study stakeholders.
Regulatory & Compliance- Prepare and submit regulatory documents to the IRB through iRIS.
- Support protocol submissions, study amendments, continuing reviews, and safety reporting requirements.
- Ensure research activities comply with institutional policies, Good Clinical Practice (GCP), FDA regulations, and human subject protection standards.
- Recognize when research agreements (MTAs, CDAs, DUAs, DTAs, etc.) are required and coordinate with appropriate parties.
- Identify adverse events (AEs), support evaluation of reportability, and collaborate with investigators regarding event assessment.
Data & Research Administration- Collect, enter, verify, and maintain research data to ensure accuracy, completeness, and integrity.
- Utilize systems including OnCore, eREG, REDCap, and Epic/Maestro Care to manage research protocols and participant activities.
- Monitor data quality trends and assist with quality assurance activities.
- Develop reports, study summaries, visualizations, and progress updates for investigators and research teams.
- Support data sharing, repository submission, and FAIR data practices when appropriate.
Scientific Contributions- Assist with grant proposals, research presentations, posters, publications, and dissemination of research findings.
- Contribute to scientific publications and presentations as an author or co-author.
- Participate in feasibility assessments for new studies and provide operational recommendations.
Leadership & Collaboration- Support onboarding and training of research staff and study team members.
- Participate in multidisciplinary meetings and collaborate across clinical, research, and administrative teams.
- Maintain current knowledge of Duke research processes, regulatory requirements, and clinical research best practices.
- Demonstrate adaptability, resilience, and a commitment to continuous learning.
Minimum QualificationsEducation/Training- Completion of an Associate's degree.
Experience- Work requires a minimum of two years of relevant research experience.
- Completion of the DOCR North Carolina State Approved Clinical Research Apprenticeship Program may substitute for one year of required experience.
Skills- Ability to effectively use computing software and web-based applications, including Microsoft Office products and internet browsers.
Preferred Qualifications- Bachelor's degree in Health Science, Biological Science, Public Health, Nursing, or a related field.
- Experience coordinating clinical research studies.
- Experience with IRB submissions, regulatory compliance, and sponsor communications.
- Familiarity with OnCore, Epic/Maestro Care, REDCap, eREG, and electronic data capture systems.
- Experience processing human biospecimens and maintaining laboratory documentation.
- Strong organizational skills and attention to detail.
- Ability to manage multiple studies and priorities simultaneously.
- Excellent written and verbal communication skills.
Desired Competencies- Knowledge of Good Clinical Practice (GCP), FDA regulations, and human subject protections.
- Ability to work independently while collaborating effectively in a multidisciplinary academic environment.
- Strong critical thinking and problem-solving skills.
- Commitment to advancing innovative research that improves outcomes for patients with pulmonary and critical illness.
- Ability to navigate complex research environments and build productive working relationships with diverse stakeholders.
Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $61,026.00 to USD $101,959.00. 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 goesbeyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/
