Regulatory Coordinator - Georgetown University Medical Center

Located in a historic neighborhood in the nation's capital, Georgetown offers rigorous academic programs, a global perspective, exciting ways to take advantage of Washington, D.C., and a commitment to social justice. Our community is a tight knit group of remarkable individuals interested in intellectual inquiry and making a difference in the world.

Requirements

Regulatory Coordinator , Conditionally Reprogrammed Cells (CRC) Lab - Georgetown University Medical Center

This position is responsible for participating in all regulatory related activities for the clinical research coordinator shared resources program. Regulatory coordinator will prepare, maintain, and coordinate regulatory submissions and documentation in compliance with institutional, state, and federal guidelines for investigator initiated, sponsor-initiated, and other clinical research studies. Duties include but are not limited to:

Industry Sponsored Trials

• Responsible for coordinating and facilitating CRC and IRB submissions including, but not limited to: initial submissions, amendments, ICF changes, progress reports, continuing reviews, and deviations while ensuring regulatory compliance
• Responsible for entering study information and ensuring accuracy of information in Oncore
• Communicates with investigators and research staff (study team) throughout the various stages of the study life cycles
• Informs research personnel about new regulatory policies, procedures, ICF changes, and protocol amendments
• Responsible for the creation and revisions to informed consent and HIPAA forms
• Responsible for maintaining essential regulatory documents including FDFs, 1572s, DOA logs, and other study-related documentation
• Prepares for and participates in sponsor monitoring visits and audits.

NCTN Trials

• Responsible for coordinating and facilitating CRC and IRB submissions including, but not limited to: initial submissions, amendments, ICF changes, progress reports, continuing reviews, and deviations while ensuring regulatory compliance
• Responsible for entering study information and ensuring accuracy of information in Oncore
• Communicates with investigators and research staff throughout the various stages of the study life cycles
• Informs research personnel about new regulatory policies, procedures, ICF changes, and protocol amendments
• Responsible for the creation and revisions to informed consent and HIPAA forms
• Communicates with NCI CIRB as applicable

Investigator Initiated Trials

• Responsible for coordinating and facilitating CRC and IRB submissions including, but not limited to: initial submissions, amendments, ICF changes, progress reports, continuing reviews, and deviations while ensuring regulatory compliance
• Responsible for entering study information and ensuring accuracy of information in Oncore
• Communicates with investigators and research staff throughout the various stages of the study life cycles
• Informs research personnel about new regulatory policies, procedures, ICF changes, and protocol amendments
• Responsible for the creation and revisions to informed consent and HIPAA forms
• Responsible for maintaining essential regulatory documents
• Assists investigator with clinicaltrials.gov registration and updates
• Submit and maintains annual approval for Investigational New Drug (IND) applications to the Food and Drug Administration as required.

CRMO Administration

• Assists in the development and implementation of policies and standard operating procedures (SOPS)
• Attends applicable meetings including, but not limited to disease group meetings, SIVs, IMVs, and COVs.
• Other duties as assigned by manager.

Qualifications

• A minimum of 1-3 years experience in regulatory affairs or clinical research with a bachelor's degree in a related field or a minimum of 5-7 years experience in regulatory affairs or clinical research with a high school diploma
• SoCRA, ACRP, RAPS, or CIP certification preferred
• Strong working knowledge of FDA, NCI, OHRP and/or ICH GCPs
• Outstanding organizational skills, oral and written communication skills
• Exceptional attention to detail
• Knowledge of institutional, state and federal regulatory guidelines
• Ability to learn quickly and work independently and efficiently with minimal supervision
• Ability to independently prioritize tasks, and to work under pressure

Current Georgetown Employees:

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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 cover letter and resume  for each position of interest for which you believe you are qualified. These documents are not kept on file for future positions.

Need Assistance:

If you are a qualified individual with a disability and need a reasonable accommodation for any part of the application and hiring process, please click  here  for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at 202-687-4798 or  ideaa@georgetown.edu .

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 .