Senior Director of Research Oversight - Georgetown University Medical Center

Location
Washington D.C.
Posted
Jul 04, 2018
Closes
Oct 03, 2018
Function
Executive, Director
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

Senior Director of Research Oversight - Georgetown University Medical Center

The Senior Director leads and manages the Office of Research Oversight (ORO), a new office that reflects the ongoing commitment of GU to harmonize research administration across all campuses. The ORO includes research support and compliance functions and deals with certain other matters affecting the conduct and integrity of research at the Medical Center and Main Campus (and, for certain functions, at the Law Center campus).  Reporting to both the GUMC Dean for Research and the Vice Provost for Research on the Main Campus, the Senior Director has duties that include but are not limited to:

  • Provides leadership in establishing the ORO.
  • Develops, implements, and oversees the effectiveness of policies and procedures in relevant compliance areas.
  • Develops programs and implements training for the University Research community in accordance with GU policy and federal regulations regarding ORO activities - e.g., the responsible conduct of research training program to meet PHS training requirements
  • Oversees the work of the Office of Research Quality Assurance (ORQA) to effectively a) provide appropriate outreach and training for faculty and others who are involved in human subjects and other research projects; and b) conduct for-cause and not-for-cause monitoring of human subjects and other protocols.
  • Oversees the administration of the university's Research Integrity policies and procedures, including the conduct of inquiries and investigations regarding potential research misconduct;
  • Provides oversight for the implementation of the University's Financial Conflict of Interest Policy for the Main Campus and Medical Center, ensuring that annual and investigator study-specific disclosures are maintained, and that appropriate conflicts management protocols are established and followed; and reporting to sponsors (e.g., government agencies) as required by law, regulation, and/or university policies and procedures.
  • Oversees university-wide compliance with federal Export Control regulations (including the Export Administration Regulations, the International Trafficking in Arms Regulations, and the Office of Foreign Asset Controls requirements);
  • Oversees Occupational Health functions related to the conduct of research (including biohazardous and radioactive materials); and supports the Human Subjects Institutional Officer (IO) and Vertebrate Animals IO in meeting the requirements of the University's Federal Wide Assurance (FWA)
  • Coordinates the University's responses to federal and other external agency audits, inquiries, or reviews related to non-financial research activities; where appropriate, files reports with government agencies (e.g., annual ORI report of misconduct proceedings related to PHS supported research); and assists with appropriate agency inspections and site visits.
  • Serves on relevant committees and working groups as assigned.
  • Cultivates an effective, collaborative relationship with GU regulatory committees (such as, Institutional Review Board(s), Georgetown University Animal Care and Use Committee (GUACUC), and Radiation Safety, Biosafety, Research Integrity) and other research-related committees (such as, Joint Operations Oversight Committee for Clinical Research, Research Committee, and Shared Resources Oversight Committee), including liaison for research compliance activities with Georgetown-Howard Universities Center for CTSA institutions and other local CTSA institutions.
  • Provides information and data to the IRB Office and GUACUC Office, consistent with the regulatory functions overseen by the ORO, e.g., working with the IRB on matters of financial conflict of interest on clinical trials.
  • Where appropriate, interacts with government oversight agencies.

Requirements

  • Master's degree or higher in science or social science or a Juris Doctor degree
  • 8 years of relevant experience
  • Knowledge, experience, and demonstrated skill in interpreting regulations governing research involving human subjects
  • A deep understanding of legal, ethical, and compliance issues
  • Familiarity with medical and scientific principles
  • Familiarity with a university or health care setting
  • Excellent communications skills
  • Proven ability to interact with a broad spectrum of constituencies, including faculty, research subjects, researchers, administrators, staff, students and government officials
  • Direct experience with federal grant and contract requirements and a range of laws, regulations and guidance relating to sponsored research, such as the relevant Code of Federal Regulations, Office for Human Research Protections (OHRP) guidance, NSF and PHS conflict of interest and research misconduct policies, export control and OFAC regulations
  • Familiarity with the review and negotiation of sponsored project agreements
  • Experience with regulatory requirements relating to Responsible Conduct of Research

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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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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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