Regulatory Associate I

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Requirements

Job Overview

The Regulatory Associate 1 position is responsible for conducting regulatory activities for clinical trials in the Lombardi Clinical Trials Office (CTO) of Lombardi Comprehensive Cancer Center (LCCC). The incumbent will prepare, maintain, and coordinate regulatory submissions and documentation in compliance with institutional, state, and federal guidelines for multi-institutional, industry-initiated, and National Cancer Institute NCTN clinical research studies. Duties include but are not limited to:

• Create, coordinate, and facilitate regulatory submissions of oncology clinical research trials, which include, but are not limited to, initial review committee submission, protocol amendments, consent form revisions, routine progress reports and continuing review applications, serious adverse events, protocol deviations, and audit results.

• Create and revise informed consent documents, HIPAA forms, and other regulatory documentation. Submit applicable documents to study sponsors as required.

• Organize study regulatory files including regulatory submissions, essential regulatory documents, and trial communication.

• Enter new trial information, trial updates, regulatory submission data, and upload approved documents to the Clinical Trials Management System (CTMS) ensuring accuracy of data.

• Participate in study activation management activities, ensuring forms and requests are completed accurately and in a timely manner.

• Effectively and efficiently communicate trial status and updates to investigators, CRMO team members, outside departments and committees, trial sponsors, and other pertinent personnel throughout the trial lifecycle.

• Assist with compiling regulatory-related metrics for use by senior management.

• Attend assigned Disease Group meetings and provide updates on trial activity.

• Attend protocol-related training and complete all required study training in the required timeframe.

• Prepare for and participate in trial site initiation visits, monitoring visits, close-out visits, and audits.

• Submit applications to the Food and Drug Administration for Investigational New Drug (IND) applications as required.

• Maintain research practices using Good Clinical Practice (GCP) guidelines.

• Other duties as assigned.

All Lombardi CTO Regulatory Associates perform all duties in accordance with applicable laws and regulations, while adhering to Georgetown University Medical Center’s philosophies, policies, and SOPs and work in compliance with Human Subject Protection, patient confidentiality/HIPAA, and GCP.

Work Interactions

This position reports to and works closely with the Lombardi CTO Regulatory Team Manager and requires excellent communication skills and the ability to interact effectively with a wide variety of individuals.

• Regulatory Team Manager

• Disease Group members: Principal Investigators, Physicians, Clinicians

• Lombardi CTO Team Members: Clinical Research Nurses, Clinical Research Coordinators, Data Coordinators, Regulatory Coordinators, Laboratory Technicians

• External department faculty and staff: Institutional Review Board (IRB), Scientific Review Committee (SRC), Radiation Safety Committee, Office of Research Quality Assurance (ORQA), Clinical Research Operations Office (CROO), Research Pharmacy

• Clinical trial sponsors, auditors, and study monitors

Requirements and Qualifications

• Bachelor’s Degree in a science related field required.

• Three to five (3-5) years regulatory affairs or clinical research experience required.

• SoCRA, ACRP, RAPS, or CIP certification preferred.

• Strong working knowledge of FDA, NCI, OHRP, and Good Clinical Practice

• Excellent verbal and written communication skills, organizational skills, and attention to detail

• Reliability and ability to prioritize competing responsibilities

Work Mode Designation

This position has been designated as Hybrid. 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:

$47,586.00 - $87,558.13

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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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 ( .