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Regulatory Coordinator, CTRO - Biomedical Graduate Research Organization (BGRO)
Georgetown University
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Regulatory Coordinator, CTRO - Biomedical Graduate Research Organization (BGRO)

Georgetown University

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Details
Posted:
February 19, 2021
Location:
Washington, D.C.
Salary:
Open
Categories:
Legal, Staff/Administrative



Regulatory Coordinator, CTRO - Biomedical Graduate Research Organization (BGRO)


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, CTRO - Biomedical Graduate Research Organization (BGRO)

The Regulatory Coordinator participates in all regulatory related activities for the clinical research coordinator shared resources program. They prepare, maintain, and coordinate regulatory submissions and documentation in compliance with institutional IRB, state, and federal guidelines for investigator initiated, sponsor initiated, and other clinical research studies.

Reporting the Manager for Central Research, the RC has duties that include but are not limited to:

Regulatory Management - Industry Sponsored Trials
  • Coordinates and facilitates CRC and IRS submissions, e.g., initial submissions, amendments, ICF changes, progress reports, continuing reviews, and deviations while ensuring regulatory compliance.
  • Enters regulatory documents in OnCore 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.
  • Creates, and revises as appropriate, informed consent and HIPAA forms.
  • Maintains essential regulatory documents including FDFs, 1572s, DOA logs, and other study-related documentation.
  • Prepares for and participates in sponsor monitoring visits and audits.


Regulatory Management - Oncology Trials
  • Coordinates and facilitates CRC and IRS submissions, e.g., initial submissions, amendments, ICF changes, progress reports, continuing reviews, and deviations while ensuring regulatory compliance.
  • Enters 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.
  • Creates, and revises as appropriate, informed consent and HIPAA forms.
  • Communicates with NCI CIRS as applicable.


Regulatory Management - Investigator Initiated Trials
  • Coordinates and facilitates CRC and IRS submissions including, e.g., initial submissions, amendments, ICF changes, progress reports, continuing reviews, and deviations while ensuring regulatory compliance.
  • Enters 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.
  • Creates, as revises as appropriate, informed consent and HIPAA forms.
  • Maintains essential regulatory documents.
  • Assists investigator with clinicaltriasl.gov registration and updates.
  • Submit and maintains annual approval for Investigational New Drug (IND) applications to the Food and Drug Administration as required.


CRSC
  • 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.
  • CRN and CRSC meetings.


Qualifications
  • Bachelor's degree and 1 to 3 years of experience in regulatory affairs or clinical research OR high school diploma with 5 to 7 years of experience in regulatory affairs or clinical research
  • Strong working knowledge of FDA, NCI, OHRP and/or ICH GCPs
  • Outstanding organizational skills
  • Verbal 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
  • Preference for SOCRA, ACRP, RAPS, or CIP certification


Current Georgetown Employees:

If you currently work at Georgetown University, please exit this website and login to GMS (gms.georgetown.edu) using your Net ID and password. Then select the Career worklet on your GMS Home dashboard to view Jobs at Georgetown.

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.

Benefits:

Georgetown University offers a wide variety of comprehensive and competitive benefits. Benefits packages include comprehensive health, dental and vision plans, disability and life insurance coverage, retirement savings programs, tuition assistance, voluntary insurance options (including group legal, accident, and critical illness), and much more. Whatever your need, the Office of Faculty and Staff Benefits will be standing by to support you. You can learn more about the benefits offered to eligible faculty and staff at https://benefits.georgetown.edu or view the online interactive benefits guide for more information.


To apply, visit https://georgetown.wd1.myworkdayjobs.com/en-US/Georgetown_Admin_Careers/job/Medical-Center/Regulatory-Coordinator--CTRO---Biomedical-Graduate-Research-Organization--BGRO--_JR09836





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About Georgetown University
Established in 1789, Georgetown is the nation's oldest Catholic and Jesuit University. Georgetown is one of the world's leading academic and research institutions, offering a unique educational experience that prepares the next generation of global citizens to lead and make a difference in the world.
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