Regulatory Associate, Clinical Research Management Office - Lombardi Comprehensive Cancer Center - Georgetown University Medical Center

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Requirements

Regulatory Associate, Clinical Research Management Office - Lombardi Comprehensive Cancer Center - Georgetown University Medical Center

Georgetown’s Clinical Research Management Office (CRMO) provides administrative, nursing, and data management support for cancer treatment clinical trials conducted by Lombardi Investigators. This includes all regulatory documents, IRB submissions, budget and contract negotiations, consenting of subjects, case management of patients while on study, side effect management, completion of case report forms, meeting with monitors, maintaining trial information on the Lombardi website , and design of electronic case report forms for institutional trials.

Job Overview

The Research Associate conducts regulatory activities for clinical trials in the Clinical Research Management Office (CRMO) of the Lombardi Comprehensive Cancer Center (LCCC), and comply with institutional, state, and federal guidelines for investigator-initiated, industry-initiated, and National Cancer Institute’s National Cancer Trials Network (NCTN) clinical research studies. Responsibilities 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
• Perform all duties in accordance with applicable laws and regulations
• Adhere to Georgetown University Medical Center’s philosophies and policies
• Work in compliance with Human Subject Protection, patient confidentiality/HIPAA, and GCP

Work Interactions

Reporting to - and working closely- with the CRMO Regulatory Manager, the

Regulatory Associate interacts routinely with:

• Disease Group members: Principal Investigators, Physicians, Clinicians
• Clinical Research Management Office (CRMO) members: Clinical Research Nurses, Clinical Research Coordinators, Data Managers, Regulatory Coordinators, and Laboratory Technicians
• External department faculty and staff – for example, Institutional Review Board (IRB), Clinical Research Committee (CRC), 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
• 3 to 5 years of regulatory affairs or clinical research experience
• Strong working knowledge of FDA, NCI, OHRP, and Good Clinical Practice
• Excellent communication skills (verbal and written) and the ability to interact effectively with a wide variety of individuals
• Excellent organizational skills and attention to detail
• Reliability and ability to prioritize competing responsibilities

Preferred Qualification

SoCRA, ACRP, RAPS, or CIP certification

Work Mode: 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 and AAP positions can be found on the Department of Human Resources Mode of Work Designation .

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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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Need some assistance with the application process? Please call 202-687-2500. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website .

EEO Statement:

Georgetown University is an Equal Opportunity/Affirmative Action Employer  fully dedicated to achieving a diverse faculty and staff.  All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, national origin, age, sex (including pregnancy, gender identity and expression, and sexual orientation), disability status, protected 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 .