Regulatory Associate, Clinical Research Management Office - Georgetown University Medical Center

Location
Washington D.C.
Posted
Mar 22, 2018
Closes
Apr 27, 2018
Industry
Education, Research
Hours
Full Time
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 Associate, Clinical Research Management Office - 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 Care (LCCC) Investigators. This includes 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 the Clinical Research Management Office of the Lombardi Comprehensive Cancer Center. S/he prepares, maintains, and coordinates regulatory submissions and documentation in compliance with institutional, state, and federal guidelines for investigator-initiated, sponsor-initiated, and National Cancer Institute (NCI) National Clinical Trials Network (NCTN) clinical research studies. The Regulatory Associate streamlines processes and assists in the implementation of standardized functions. Reporting to the Regulatory Manager, the Regulatory Associate has duties that include but are not limited to:

Regulatory Management - Industry Sponsored Trials

  • Administers the coordination and facilitation of  Council on Research & Creativity (CRC) and Institutional Review Board (IRB) submissions, including initial submissions, amendments, Informed Consent Form (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 (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 the informed consent and HIPAA forms.
  • Maintains essential regulatory documents, such as Financial Disclosure Forms (FDFs), Form FDA 1572s, Delegation of Authority (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 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 to informed consent and HIPAA forms.
  • Communicates with NCI Central Institutional Review Board (CIRB) as applicable.

Regulatory Management - Investigator Initiated Trials

  • Coordinates and facilitates CRC and IRB submissions, including 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 to 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, such as disease group meetings, Site Initiation Visits (SIV), Interim Monitoring Visits (IMVs), and Clinical Outcome Variables Scale (COVS).

Requirements

  • Bachelor's degree in a related field
  • 3 to 5 years of experience in regulatory affairs or clinical research
  • Preference for Society of Clinical Research Associates (SoCRA), Association of Clinical Research Professionals (ACRP), Regulatory Affairs Professionals Society (RAPS), or Certified IRB Professional (CIP) certification
  • Strong working knowledge of Food and Drug Administration (FDA), National Cancer Institute (NCI), Office for Human Research Protections (OHRP), and/or  International Conference on Harmonisation Good Clinical Practices (ICH GCPs).
  • Outstanding organizational skills, and verbal and written communication skills; and the ability to interact effectively with a wide variety of individuals, such as including investigators, clinical research coordinators, administrative staff, and representatives from cooperative groups, clinical research organizations, other institutions, and pharmaceutical companies.
  • Exceptional attention to detail
  • Knowledge of institutional, state, and federal regulatory guidelines
  • Ability to learn quickly, and to work independently and efficiently with minimal supervision
  • Ability to independently prioritize tasks and to work successfully under pressure

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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

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.

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