Regulatory Coordinator

Duke PA; Durham, Northern (NC, KY); Hybrid; USD 61,000 - 102,000; Full time

Job summary

The Ophthalmology Clinical Research Unit (CRU) at the Duke Eye Center seeks a Regulatory Coordinator to support complex ophthalmology clinical trials and ensure regulatory compliance. You will contribute to data integrity and patient safety across multiple studies.

Responsibilities include coordinating regulatory submissions (IRB, IND, FDA forms), maintaining study documents, and collaborating with investigators and sponsors.

Qualifications

• Associate’s degree required.
• Minimum of two years of research or regulatory experience.
• Experience with regulatory submissions (IRB, IND, FDA forms) and clinical trial compliance preferred.
• Proficiency in Microsoft Office and web-based applications including electronic medical records.

Responsibilities

• Coordinate regulatory submissions, documentation, and safety reporting activities across multiple clinical research studies in compliance with applicable regulations, institutional policies, SOPs, and study protocols.
• Prepare and maintain IRB, FDA, sponsor, and other regulatory submissions and documentation, including addressing regulatory questions and issues in collaboration with investigators and study teams.
• Manage study-level regulatory documentation and compliance activities, including preparation for monitoring visits, audits, study closeout, and document storage.
• Coordinate site visits and communicate effectively with sponsors, CROs, investigators, and other research stakeholders to support successful study execution and compliance.
• Train and mentor research staff on regulatory requirements, institutional processes, and clinical research compliance, while providing oversight of junior staff as appropriate.

Skills

Regulatory compliance

IRB submissions

FDA submissions

Clinical research

Microsoft Office

Electronic medical records

Communication skills

Education

Associate’s degree

Tools

iRIS

OnCore

eREG Forte

Job description

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Be You.

The Ophthalmology Clinical Research Unit (CRU) within the Duke Eye Center is seeking a Regulatory Coordinator to join our team. In this role, you will play a critical part in supporting complex ophthalmology clinical trials, ensuring regulatory compliance. This position will also serve a key role to ensure data integrity, and patient safety across multiple studies.

You will work at the intersection of regulatory operations, clinical data management, and safety reporting, supporting cutting-edge ophthalmology research. Your work will directly contribute to the advancement of innovative therapies while collaborating with multidisciplinary teams across Duke.

Minimum Requirements:

• Associate’s degree required
• Minimum of two (2) years of research or regulatory experience
• Completion of the DOCR North Carolina state-approved Clinical Research Apprenticeship may substitute for one year of experience
• Proficiency in Microsoft Office and web-based applications, including electronic medical records

Preferred Qualifications:

• Experience preparing clinical trial data for monitoring visits
• Strong organizational skills with the ability to manage multiple complex studies simultaneously
• Excellent written and verbal communication skills
• Ability to quickly learn new clinical research systems (e.g., iRIS, OnCore, eREG Forte)
• Experience with regulatory submissions (IRB, IND, FDA forms) and clinical trial compliance

Other Requirements:

• Ability to maintain required certifications and training for clinical research compliance
• Adherence to institutional policies, SOPs, and federal regulations

This position is:

• Onsite. The work is performed on-site or at a designated assignment location.

Be Bold.

• Coordinate regulatory submissions, documentation, and safety reporting activities across multiple clinical research studies in compliance with applicable regulations, institutional policies, SOPs, and study protocols.
• Prepare and maintain IRB, FDA, sponsor, and other regulatory submissions and documentation, including addressing regulatory questions and issues in collaboration with investigators and study teams.
• Manage study-level regulatory documentation and compliance activities, including preparation for monitoring visits, audits, study closeout, and document storage.
• Coordinate site visits and communicate effectively with sponsors, CROs, investigators, and other research stakeholders to support successful study execution and compliance.
• Train and mentor research staff on regulatory requirements, institutional processes, and clinical research compliance, while providing oversight of junior staff as appropriate.

Choose Duke.

At Duke, you'll join a nationally recognized academic medical center and research enterprise dedicated to transforming health through discovery, innovation, and collaboration. You'll work alongside world-class clinicians, researchers, and educators while helping advance treatments and improve the lives of patients affected by vision-related conditions.

Duke offers:

• 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.

Your total compensation goes beyond 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/

Equal Opportunity Employer:

Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender,gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy- related conditions), sexual orientation, or military status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions:

Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: [e-mail]; phone: [phone]).

Nearest Major Market:

Durham

Nearest Secondary Market:

Raleigh

Read more about Duke’s commitment to affirmative action and nondiscrimination at hr.duke.edu/eeo.