Administrative Specialist, Office of Regulatory Affairs - Georgetown University Medical Center

Location
Washington D.C.
Posted
Apr 11, 2018
Closes
May 02, 2018
Function
Administrative
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

Administrative Specialist, Office of Regulatory Affairs - Georgetown University Medical Center

The Georgetown University Office of Regulatory Affairs (ORA) provides oversight and guidance in human subject research; animal care and use; biosafety; chemical safety; radiation safety; occupational health; export controls; conflict of interest; handling of hazardous, controlled or regulated substances; material transfers; and research misconduct. ORA's mission, working in cooperation with the University community, is to facilitate research integrity in the design, conduct, review and reporting of research, and to promote adherence to applicable laws, regulations, and professional and ethical standards.

The Administrative Specialist has responsibility for administering and monitoring compliance with GUMC's financial Conflict of Interest (COI) policies and electronic disclosure systems in accordance with applicable laws, regulations, university, and medical center policies and practices.  Reporting to the Senior Associate Vice President for Regulatory Affairs (“SAVP”), the Administrative Specialist has duties that include but are not limited to:

Conflict of Interest Compliance

  • Assists in on-going improvement of GUMC policies and practices related to COIs, as well as implementing procedures for compliance and working with UIS to develop, monitor, and update as needed new compliance tools, including revised disclosure systems and new websites for public disclosure of related faculty extramural financial interests and PHS public disclosure requirements.  
  • Assists with ongoing management of university eCOI system.
  • Works with the SAVP in developing, conducting, and monitoring completion of COI required training programs for faculty, staff,  and investigators, in compliance with GU and GUMC policies and as required by law.

Financial Disclosures

  • Serves as the primary contact for Office of Sponsored Research and IRB for financial disclosures of researchers.
  • Prepares conflict management plans for review by SAVP, followed by execution and implementation by researchers, and advises IRB of required consent form modifications and/or other necessary actions.  
  • Prepares and submits initial and updated reports to federal agencies as necessary to comply with federal COI rules and regulations.
  • Assists with any COI related reports for government and other entities. 

Administrative Management

  • Prepares materials for relevant committee meetings (Conflict Advisory Panel), takes and distributes minutes; maintains an Excel database to track all Investigators' financial COIs and conflict management plans (CMPs); and maintains a CMP oversight system. 
  • Interacts with, and act as liaison for, ORA, with regulatory committees (such as the IRB and IACUC), university counsel, internal audit, ethics and compliance, HR, and investigators in implementation of COI policies and practices.
  • Assists the university's Research Integrity Officer (RIO) by assisting with management of university research integrity cases as assigned by the RIO.
  • Manages the ORA website and makes changes as needed.

Requirements

  • Bachelor's degree
  • 4 years of professional experience
  • Proficiency in use of computers and electronic systems and software, particularly Word and Excel
  • Ability to work independently
  • Ability to accurately read and understand federal and state laws and regulations, as well as biomedical and social and behavioral grant applications, and to apply legal and university requirements, policies, and practices
  • Ability to understand financial and business dealings of faculty and financial and business dealings of the university, such as  faculty startup companies, university incubators, and venture capital relationships
  • Ability to maintain confidentiality of faculty and staff information and university confidential information
  • Ability to write memorandum for general distribution describing federal and university information

Current Georgetown Employees:

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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. 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.

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