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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 affairs 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 Practice (GCP) guidelines.
Responsibilities
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
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
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.
Pay Range $47,586.00 - $87,558.13
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.
To apply, visit https://georgetown.wd1.myworkdayjobs.com/en-US/Georgetown_Admin_Careers/job/Medical-Center/Regulatory-Coordinator_JR24174
#J-18808-Ljbffr
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 affairs 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 Practice (GCP) guidelines.
Responsibilities
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
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
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.
Pay Range $47,586.00 - $87,558.13
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.
To apply, visit https://georgetown.wd1.myworkdayjobs.com/en-US/Georgetown_Admin_Careers/job/Medical-Center/Regulatory-Coordinator_JR24174
#J-18808-Ljbffr