Regulatory Coordinator - Georgetown University Medical Center

Georgetown University; Toronto; On-site; CAD 80,000 - 100,000; Full time

Job description

Overview

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.

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 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.

Pay Range

The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is: $21.16 - $35.29

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.

Equal Employment Opportunity (EEO) Statement

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, 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.