Clinical Research Coordinator 2

Be You. Be Bold. Choose Duke.

Clinical Research Coordinator II

Be You.

Be Bold.

What You'll Do

Clinical 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 Qualifications

Education/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.

Choose Duke.

Ready to Make a Difference?

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.