Regulatory Coordinator

Georgetown University comprises two unique campuses in the nation's capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world.

Requirements

Job Overview

The Regulatory Coordinator plays a critical role in ensuring regulatory compliance and oversight of a portfolio of clinical trials overseen by the Clinical Research Organization (CRO) at Georgetown University Medical Center (GUMC). Working under the direct supervision of the Director of the CRO, the CRC will manage regulatory for complex clinical trials across multiple studies and therapeutic areas. The CRO supports research efforts for various clinical departments within GUMC, and the Regulatory Coordinator plays a critical role in ensuring that all trials are conducted in strict accordance with study protocols, regulatory requirements, institutional policies, and Good Clinical Practical (GCP) guidelines. Additional duties include but are not limited to:

• Prepare and submit required regulatory documents (e.g., IRB applications, amendments, safety reports)

• 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

Work Interactions
 

This position reports directly to the Director of the Clinical Research Organization (CRO), who in turn reports to the Vice President for Biomedical Graduate Education and Research. The Regulatory Coordinator collaborates closely with a wide range of stakeholders across the clinical research enterprise. This includes daily interaction with principal investigators, study coordinators, data managers, and clinical trial sponsors. The role also requires frequent communication with the Institutional Review Board (IRB) and compliance offices. The Regulatory Coordinator often serves as the primary point of contact for regulatory correspondence and plays a key role in facilitating study start-up and ongoing regulatory maintenance. Strong interpersonal skills are essential, as the position involves navigating complex regulatory requirements while supporting diverse research teams and maintaining positive, professional relationships throughout GUMC.
 

Requirements and Qualifications

• Bachelor's degree in a health science, life science, or related field

• Minimum of 2 years of experience in regulatory affairs or clinical research

• FDA, ICH-GCP)Familiarity with regulatory and ethical requirements related to human subjects research (e.g., IRB,

• 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 Requirements and 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 Designation

This position has been designated as On-Campus. Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University. Such review may necessitate a change to a position's mode of work designation. Complete details about Georgetown University's mode of work designations for staff positions can be found on the Department of Human Resources website:

Pay Range:

The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is:

Compensation is determined by a number of factors including, but not limited to, the candidate's individual qualifications, experience, education, skills, and certifications, as well as the University's business needs and external factors.

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Submission Guidelines:

Please note that in order to be considered an applicant for any position at Georgetown University you must submit a resume for each position of interest for which you believe you are qualified. Documents are not kept on file for future positions.

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EEO Statement:

GU 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, matriculation, national origin, race, religion, personal appearance, political affiliation, sex, sexual orientation, veteran status, or any other characteristic protected by law.

Benefits:

Georgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the Department of Human Resources website.