Regulatory Associate/Specialist, Clinical Research Management Office, Lombardi Comprehensive Cancer

6 days left

Location
Washington D.C.
Posted
Jul 24, 2017
Closes
Oct 28, 2017
Industry
Research
Hours
Full Time
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Requirements

Regulatory Associate/Specialist, Clinical Research Management Office, Lombardi Comprehensive Cancer Center (LCCC) - Georgetown University Medical Center

Georgetown Lombardi Comprehensive Cancer Center (LCCC) clinicians are dedicated to providing the best professional care, delivered with compassion, for all patients. Lombardi's internationally-renowned physicians treat virtually every type of cancer, including breast, lung, colorectal, prostate, head and neck, and cancers of the blood. Along with cutting-edge cancer care, we offer a program of innovative clinical trials and a full range of supportive care services to improve our patients' health and quality of life.  The Clinical Research Management Office (CRMO)  is a shared institutional resource of the Lombardi Comprehensive Cancer Center at Georgetown, provides administrative, nursing, and data management support for cancer treatment clinical trials conducted by Lombardi Investigators.

The Regulatory Associate/Specialist participates in all regulatory related activities for the CRMO, and oversees, prioritizes, tracks and reports on the regulatory functions relating to Oncology research projects.  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 the Regulatory Manager, the Regulatory Associate/Specialist has duties that include but are not limited to:

Regulatory Management - Industry Sponsored Trials

  • Coordinates and facilitates CRC and IRB submissions - for example, 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 - for example, 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.
  • Communicates with NCI CIRB as applicable.

Regulatory Management - Investigator Initiated Trials

  • Coordinates and facilitates CRC and IRB submissions - for example, 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 - for example, disease group meetings, SIVs, IMVs, and COVs.

Requirements

  • Master's degree in Biology, Pharmacy, Molecular Biology or Biotechnology
  • At least 1 year of experience required in the field of regulatory affairs - preference for SoCRA, ACRP, RAPS, or CIP certification
  • Strong working knowledge of FDA, NCI, OHRP and/or ICH GCPs
  • Knowledge of institutional, state and federal regulatory guidelines.
  • Strong working knowledge of FDA, NCI, OHRP and ICH GCPs
  • Exceptional attention to detail

This position is located in Washington, D.C.

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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.