Regional Study Coordinator Jobs in Raleigh, NC (NOW HIRING)

• Serve as the primary coordinator for ophthalmology clinical research studies.
• Screen, recruit, consent, and retain study participants according to protocol requirements.
• Schedule and coordinate research visits, procedures, testing, and follow-up activities.
• Conduct and document study visits, interviews, and participant interactions.
• Manage participant reimbursement and study-related communications.
• Implement strategies to maintain participant recruitment and retention goals.
• Collaborate closely with investigators, clinical staff, sponsors, and research partners.

• Prepare and maintain regulatory documentation throughout the study lifecycle.
• Develop and submit IRB applications, amendments, continuing reviews, and reportable events through iRIS.
• Coordinate FDA submissions and regulatory communications in partnership with institutional offices and investigators.
• Recognize when agreements such as MTAs, CDAs, DUAs, and DTAs are required and facilitate appropriate reviews.
• Support study monitoring visits, audits, inspections, and sponsor reviews.
• Address findings and implement corrective actions when necessary.
• Ensure studies are conducted in compliance with Good Clinical Practice (GCP), institutional policies, and applicable regulations.

• Manage all aspects of investigational product accountability, including receipt, storage, inventory, tracking, and documentation.
• Coordinate randomization and blinding/unblinding activities according to protocol requirements.
• Maintain study-level documentation and essential regulatory files.
• Support international research activities and associated study documentation when applicable.
• Assist with study feasibility assessments and operational planning.
• Prepare studies for closeout and long-term records management.

• Collect, enter, review, and maintain research data with a high level of accuracy and integrity.
• Monitor data quality and identify trends requiring escalation or corrective action.
• Develop or support data collection tools and quality assurance processes.
• Ensure compliance with data security, confidentiality, and data sharing requirements.
• Utilize research technologies, electronic data capture systems, EHR platforms, OnCore, and eREG systems to support study operations.
• Create reports, summaries, data visualizations, and study progress updates for investigators and stakeholders.

• Conduct literature reviews and contribute to protocol development.
• Assist with grant applications and funding proposals.
• Support preparation of scientific presentations, abstracts, manuscripts, and publications.
• Contribute to dissemination of research findings through posters, presentations, and publications.

• Serve as a resource for research staff and may train or mentor team members.
• Participate in multidisciplinary meetings and sponsor interactions.
• Contribute to process improvement initiatives and development of standard operating procedures.
• Maintain professional certifications and stay current with evolving clinical research practices.
• Demonstrate organizational awareness, adaptability, and strong collaborative skills across Duke's research enterprise.

• Perform ophthalmic research-related assessments and coordinate protocol-specific clinical procedures.
• Support participant care activities associated with ophthalmology research protocols.
• Collaborate with ophthalmologists, research staff, and study sponsors to ensure successful protocol execution.
• Maintain participant safety and adherence to study requirements.

• Experience coordinating clinical research studies in a healthcare, academic, or research environment.
• Knowledge of clinical research regulations, Good Clinical Practice (GCP), and human subject protections.
• Strong organizational, communication, and project management skills.
• Experience working with research databases, electronic health records, and study management systems.

• Certified Ophthalmic Assistant (COA) or Certified Ophthalmic Technician (COT) certification strongly preferred/required.
• Experience supporting ophthalmology clinical research studies.
• Familiarity with FDA-regulated studies, investigational products, and sponsor interactions.
• Experience using OnCore, eREG, iRIS, and related clinical research systems.

• A collaborative and inclusive work environment.
• Opportunities for professional growth and career development.
• Access to cutting-edge research and innovative technologies.
• Comprehensive benefits and wellness programs.
• The opportunity to make a meaningful impact on patient care and scientific advancement.

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.