Regulatory Coordinator - Georgetown University Medical Center

Overview

Regulatory Coordinator plays a critical role in ensuring regulatory compliance and oversight of a portfolio of clinical trials in the Center for Translational Transplant Medicine (CTTM) and the Department of Surgery (DoS) at Georgetown University Medical Center (GUMC). Working under the supervision of the Research Director of CTTM, the Regulatory Coordinator will manage regulatory matters for complex clinical trials across multiple studies and therapeutic areas. The CTTM supports research efforts for various clinical trials within CTTM and DoS at GUMC, and the Regulatory Coordinator ensures that all trials are conducted in accordance with study protocols, regulatory requirements, institutional policies, and Good Clinical Practice (GCP) guidelines.

Responsibilities

• Prepare and submit required regulatory documents (e.g., IRB applications, amendments, safety reports, protocol deviations)
• Maintain accurate and up-to-date regulatory files for clinical research studies
• Ensure compliance with institutional, federal, and sponsor regulations
• Communicate with investigators, study staff, and regulatory agencies to support study approvals and updates

Qualifications

• Bachelor’s degree in health science, life science, or related field
• Minimum of 2 years of experience in regulatory affairs or clinical research
• Familiarity with regulatory and ethical requirements related to human subjects research (e.g., IRB, FDA, ICH-GCP, IND/IDE)
• Strong attention to detail and organizational skills
• Excellent written and verbal communication
• Ability to manage multiple priorities and meet deadlines
• Critical thinking and problem-solving abilities
• Proficiency in Microsoft Office and familiarity with regulatory databases

Preferred Qualifications

• Master’s degree or regulatory certification (e.g., SOCRA, ACRP)
• Experience working in an academic medical center or large research institution
• Knowledge of electronic regulatory systems and clinical trial management systems (e.g., OnCore, REDCap)

Work Mode

On-Campus

Pay Range

$21.16 - $35.29

Equal Opportunity

Georgetown University is an Equal Opportunity Employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to age, citizenship, color, disability, family responsibilities, gender identity and expression, genetic information, marital status, national origin, race, religion, sex, sexual orientation, veteran status, or any other characteristic protected by law.