Regulatory Associate, Clinical Research Management Office, Lombardi Comprehensive Cancer Center - G

Location
Washington D.C.
Posted
Jul 13, 2017
Closes
Sep 29, 2017
Industry
Research
Hours
Full Time
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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 Comprehensive Cancer Center (LCCC) Investigators - including 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 Lombardi website, design of electronic case report forms for institutional trials.

The Regulatory Associate participates in all regulatory related activities for Lombardi's CRMO. She/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 the Regulatory Manager, the Research Associate has duties that include but are not limited to:

Regulatory Management - Industry Sponsored Trials

  • 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.
  • 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 - NCTN Trials

  • 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.
  • 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.
  • Creates and revises informed consent and HIPAA forms.
  • Communicates with NCI CIRB as applicable.

Regulatory Management - Investigator Initiated Trials

  • 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 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.
  • Maintains essential regulatory documents.
  • Assists investigator with clinicaltrials.gov registration and updates.
  • Submits 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 LCCC meetings, including but not limited to disease group meetings, SIVs, IMVs, and COVs.

Requirements

  • High school diploma and 5 - 7 years of experience in regulatory affairs or clinical research OR  Bachelor's degree in a related field and 1 - 3 years of experience in regulatory affairs or clinical research  
  • Strong working knowledge of FDA, NCI, OHRP and/or ICH GCPs
  • Outstanding organizational skills, and 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

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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.

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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, disability status, protected veteran status, or any other characteristic protected by law.