Regulatory Associate - 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

As one of approximately 140 academic health and science centers in the United States, Georgetown University Medical Center seeks to provide, in a synergistic fashion, excellence in education — training physicians, nurses and other health care professionals, as well as biomedical scientists — and cutting-edge interdisciplinary research collaboration, enhancing our basic science and translational biomedical research capacity in order to improve human health.
The Regulatory Associate participates in all regulatory related activities for the Clinical Research Management Office (CRMO) of the Lombardi Comprehensive Cancer Center (LCCC). S/he prepares, maintains, and coordinates regulatory submissions and documentation in compliance with institutional, state, and federal guidelines for investigator initiated, sponsor-initiated, and NCI NCTN clinical research studies. Reporting to and working closely with the regulatory manager, the Regulatory Associate has additional duties that include but are not limited to:

• Coordinates and facilitates CRC and IRB submissions including, but not limited to: initial submissions, amendments, ICF changes, progress reports, continuing reviews, and deviations while ensuring regulatory compliance.
• Enters study information and ensures 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 informed consent and HIPAA forms, maintaining essential regulatory documents including FDFs, 1572s, DOA logs, and other study-related documentation.
• Prepares for and participates in sponsor monitoring visits and audits.
• Submits and maintains annual approval for Investigational New Drug (IND) applications to the Food and Drug Administration as required.
• Assists in the development and implementation of policies and standard operating procedures (SOPS).
• Attends applicable LCCC meetings.
  

Qualifications

• Bachelors Degree in a related field
• Minimum of 3-5 years 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 with 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
• SoCRA, ACRP, RAPS, or CIP certification preferred

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.


To apply, visit https://georgetown.wd1.myworkdayjobs.com/en-US/Georgetown_Admin_Careers/job/Medical-Center/Regulatory-Associate---Georgetown-University-Medical-Center_JR06408





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