Program Coordinator, Institutional Review Board (IRB) - Georgetown University Medical Center

Location
Washington D.C.
Posted
Aug 30, 2017
Closes
Oct 03, 2017
Function
Program Manager
Industry
Education
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

Program Coordinator, Institutional Review Board (IRB) - Georgetown University Medical Center

The Program Coordinator serves as the primary liaison with the commercial IRB, s/he reviews research conducted at Georgetown University and the affiliate institutions, and screens protocols and Informed Consent Forms (ICF) reviewed by the external IRBs to make sure that the local language is included in the external IRB approved ICF. Reporting to the IRB Director, the Program Coordinator has duties that include but are not limited to:

  • Screens ICF for study amendments and continuing review.
  • Verifies that all institutional conflict of interest processes have been implemented and that all study specific disclosures for all the investigators listed on a specific protocol are completed and submitted to the Conflict of Interest in the consent and approval by the external IRB.
  • Verifies if all the research members interacting with human subjects or having access to identifiable information have completed and renewed when required human subjects protection and HIPAA training.
  • Verifies if ancillary committee approval letters were uploaded into eRIC (Electronic Research Information and Compliance) by the research team.
  • Obtains the meeting minutes from commercial IRB and disseminates them to the local institution affiliated institutions for compliance and/or billing purposes.
  • Issues the institutional letter allowing the research to commence at MHRI-GU institutions for oncology research.
  • Verifies that the internal adverse events were submitted and reviewed by the GU Adverse Events Subcommittee and reported to the external IRB.
  • Runs adverse events reports, and reviews the research team's proposed plan to manage the incident, experience, or outcome, including measures to prevent similar occurrences.
  • Responds to study participants' concerns and submits the study participants' concerns to the Director of the local IRB.
  • Manages study deviations and violations as well as submits the non-compliance reports to the external IRB.

Requirements

  • Bachelor's degree
  • 4 years of administrative experience in an IRB Office 
  • Analytical, communications, and organizational skills

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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.