Clinical Research Coordinator

Duke Careers•Durham, NC

6d•$61,026 - $101,959•Onsite

About The Position

As a Clinical Research Coordinator in the Ophthalmology Clinical Research Unit (CRU), you will play a key role in advancing innovative vision research while collaborating with physicians, scientists, study participants, sponsors, and multidisciplinary healthcare teams. This position offers the opportunity to serve as a primary study coordinator supporting a diverse portfolio of clinical research studies. If you are passionate about patient-centered research, regulatory excellence, and improving outcomes through scientific discovery, we encourage you to bring your talents to Duke. As a valued member of our research team, you will independently coordinate and manage clinical research studies from study start-up through closeout while ensuring compliance with institutional, regulatory, and sponsor requirements.

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.

Nice To Haves

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.

Responsibilities

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.