Be You. Be Bold. Choose Duke.

Clinical Research Coordinator III - Ocular Immunology & Inflammation

Be You.

Be Bold.

What You'll Do

Lead Clinical Research Operations

• Coordinate and manage complex ophthalmology clinical research studies from startup through study closeout.
• Facilitate study start-up activities, including protocol implementation, operational planning, and study documentation.
• Prepare and maintain essential regulatory, sponsor, and study records.
• Manage investigational products, including receipt, inventory, storage, accountability, and participant dispensing activities.
• Support site initiation visits, monitoring visits, audits, and inspections.
• Collaborate with sponsors, CROs, Duke research offices, and institutional stakeholders.
• Utilize OnCore, eREG, Epic/Maestro Care, and other research management systems to oversee study activities and participant tracking.

Ensure Regulatory Compliance and Participant Safety

• Prepare and submit regulatory documents to Institutional Review Boards (IRBs), sponsors, and regulatory agencies.
• Support FDA submissions and regulatory communications in partnership with Duke regulatory offices and study investigators.
• Identify, document, and report adverse events and safety concerns according to protocol, sponsor, and institutional requirements.
• Conduct informed consent discussions and documentation for studies ranging from minimal-risk to complex interventional trials.
• Maintain study compliance with federal regulations, Good Clinical Practice (GCP), Duke policies, and sponsor requirements.

Support Participant Recruitment and Retention

• Screen and enroll participants for complex clinical studies.
• Implement recruitment and retention strategies to support enrollment goals.
• Evaluate barriers to enrollment and participant engagement and escalate concerns when appropriate.
• Conduct study visits and participant interactions in accordance with approved protocols.

Manage Clinical Research Data

• Collect, enter, review, and maintain high-quality research data.
• Ensure accuracy, completeness, and integrity of research records and databases.
• Assist with data quality assurance activities and resolution of discrepancies.
• Support data sharing, repository submissions, and implementation of FAIR data principles.
• Prepare reports, visualizations, study summaries, and research updates for investigators and collaborators.
• Contribute to qualitative and quantitative data analysis activities.

Advance Scientific Discovery

• Conduct literature reviews to support protocol development and study planning.
• Assist investigators with preparation of research protocols and funding submissions.
• Support development of abstracts, posters, manuscripts, and scientific presentations.
• Contribute as an author on publications and conference presentations when appropriate.

Provide Leadership and Collaboration

• Serve as a key resource for study teams and research stakeholders.
• Train and mentor research staff on study procedures, compliance requirements, and operational processes.
• Participate in departmental committees, workgroups, and professional development opportunities.
• Build productive relationships across Duke's clinical and research communities.
• Identify opportunities to improve research workflows, efficiency, and participant experience.

What We're Looking For

Minimum Qualifications

• Bachelor's degree in a health-related, scientific, or allied health field.

• Clinical research experience commensurate with Duke Clinical Research Coordinator III requirements.

• Knowledge of clinical research regulations, Good Clinical Practice (GCP), and human subject protections.
• Experience managing regulatory documentation and IRB submissions.
• Experience supporting clinical trials and complex research protocols.
• Strong organizational, project management, and documentation skills.
• Ability to work independently while effectively collaborating across multidisciplinary teams.
• Excellent verbal and written communication skills.
• Proficiency with electronic research systems and Microsoft Office applications.

Preferred Qualifications

• Certified Ophthalmic Professional credential required or strongly preferred.
• Previous ophthalmology research experience.
• Experience supporting FDA-regulated clinical studies.
• Experience using OnCore, eREG, Epic/Maestro Care, and clinical research management systems.
• Experience with sponsor-funded clinical trials and investigational products.

Type of Research

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.