Senior Director, Office of Research Oversight

Association of American Medical Colleges; Connecticut; On-site; USD 80,000 - 130,000; Full time

Job summary

An established industry player seeks a Senior Director for the Office of Research Oversight to lead compliance and regulatory initiatives. This pivotal role involves overseeing research security, conflict of interest management, and ensuring adherence to federal regulations. The ideal candidate will have a strong background in research compliance, excellent communication skills, and a commitment to ethical research practices. Join a dynamic team dedicated to enhancing research integrity and compliance across a major institution, making a significant impact in the academic and healthcare sectors.

Qualifications

• 8+ years of experience in research compliance and oversight.
• Strong understanding of legal and ethical issues in research.

Responsibilities

• Lead the implementation of Georgetown’s Research Security Program.
• Oversee compliance with federal export controls and trade sanctions laws.
• Manage investigations of research misconduct and conflict of interest.

Skills

Regulatory Compliance

Research Oversight

Conflict of Interest Management

Data Management

Communication Skills

Federal Grant Requirements

Education

Master’s Degree in Science or Social Science

JD

Job description

Job Overview

The Senior Director, Office of Research Oversight, leads and manages this office that was established (6) six years ago as the first step in Georgetown’s commitment to harmonize research administration and compliance across all campuses. The Senior Director leads Georgetown’s non-financial research compliance functions along with other regulatory matters affecting the conduct and integrity of research. The Senior Director jointly reports to the GUMC VP, BGER, and the Main Campus Vice Provost for Research but is responsible for University-wide compliance activities. Specifically, the Senior Director serves as the conflict officer for the Main Campus and Medical Center, the Research Integrity Officer, and oversees research security (new), export controls, responsible conduct of research, and other regulatory initiatives.

The Senior Director will oversee a variety of compliance areas related to the conduct of research at Georgetown as required under Georgetown’s policies and Federal and local laws, regulations, and guidance. The Senior Director will be responsible for the following activities:

• Providing leadership in establishing and leading the implementation of the University’s Research Security Program overseeing the new position of Director, Research Security and Export Controls (formerly the Export Control Officer) and ensuring the University’s compliance with new regulatory requirements associated with National Security Presidential Memorandum NSPM-33 and NSF’s Chips and Science Act legislation.
• Responsible for the implementation of the Academic Visitor’s Policy ensuring that visitors are properly screened and that researchers are provided appropriate guidance and security measures related to ensuring that their data and other intellectual property are properly secured and protected when visitors are in the lab.
• Provide oversight of Georgetown’s Outside Professional Activities Policy per Section III.C.9 of the Faculty Handbook, expand to the Medical Center, the new GU-PASS module for electronic routing and storage of disclosures designed for the Main Campus, ensure that enhancements to the GU-PASS module are designed properly, implemented, and working efficiently, preparing conflict management plans as requested by the Main Campus and Medical Center faculty affairs offices, and responding to questions from chairs and deans during the review process.
• Provide oversight in evaluating and updating Georgetown’s data management policies and procedures, analyzing and filling gaps, and providing training and assistance, as needed.
• Serving as the Research Integrity Officer responsible for oversight of Georgetown’s policies and procedures, managing investigations of allegations of research misconduct University-wide, and reporting as necessary to the federal government. Responsible for implementation of upcoming revised federal research misconduct regulations that will be effective in January 2025 and will require associated revisions to Georgetown’s policy.
• Responsible for University-wide compliance with federal export controls and trade sanctions laws including the Export Administration Regulations, the International Trafficking in Arms Regulations, and the Office of Foreign Assets Control Regulations, ensuring that proper screenings are being conducted, technology control plans are being implemented, as needed, and that applications for licenses are submitted to the relevant federal agency.
• Serving as the chief conflict of interest officer for Main Campus and Medical Center faculty and staff and MedStar physicians conducting research at MedStar Georgetown University Hospital, ensuring that employees, researchers, and physicians are complying with Georgetown’s Financial Conflict of Interest Policy, that conflict disclosures and study specific disclosures are filed timely, and that conflicts are managed appropriately as they relate to employment conflicts, sponsored research awards, and IRB protocols, and that conflicts are reported to sponsors and government agencies as required by laws and regulations. This is especially important as Georgetown expands its global footprint in the global health sector and must address conflicts that are unique to these countries and offices.
• Developing, implementing, and overseeing the effectiveness of policies, procedures, and training in the aforementioned areas.
• Support the Institutional Official (for research involving human subjects and animal subjects) in meeting the requirements of Georgetown’s Federal Wide Assurance (“FWA”).
• Coordinate Georgetown’s response to federal and other external agency audits, inquiries, or reviews related to non-financial research activities and, where appropriate, file reports with Government agencies, e.g., annual report of misconduct proceedings related to PHS funded research required by the DHHS Office of Research Integrity and assist with appropriate agency inspections and site visits.
• Serve on relevant committees and working groups as assigned.

Work Interactions

The Senior Director jointly reports to the Vice President, Biomedical Education and Research, Medical Center, and the Vice Provost for Research, Main Campus. The Senior Director has the following direct reports: 1) Director, Research Security and Export Controls (formerly the Export Control Officer), 2) Deputy Conflict of Interest Officer and Senior Research Compliance Officer; 3) Research Compliance Officer; and 4) Research Compliance Specialist.

As the lead compliance officer for Georgetown’s non-financial research (or regulatory) compliance, the Senior Director’s work regularly involves interaction with the Office of Compliance and Ethics on conflict of interest and research security matters; the General Counsel’s Office for research integrity and all other regulatory issues; the Joint Office of Research Administration (“JORA”) as ORO is actively engaged with JORA at the proposal and award stage regarding review of export controls, conflict of interest, and research security as related to those projects; the Office of Technology Commercialization related to export controls and conflicts of interest during the execution of licensing or data use agreements or as Georgetown’s intellectual property is being spun off into start-up companies; the Office of Human Subjects Protections in that each new IRB protocol or modification that includes a change in personnel or change of sponsor undergoes a conflict of interest review (and/or an export control review); University Information Services for issues related to research misconduct, data management, and research security; the Office of Environmental Health and Safety as the Senior Director serves as a member of the Radiation Safety Committee and ORO conducts export control reviews of certain shipments; the Clinical Research Operations Office and the Lombardi Cancer Center’s Clinical Research Management Office related to conflict of interest issues in the conduct of clinical trials; and MedStar Health Corporate Compliance in that ORO manages conflicts associated with MedStar physicians conducting research at MGUH. The Senior Director will collaborate, as needed, with other Georgetown regulatory committees, e.g., Institutional Review Board, Animal Care and Use Committee, Biosafety Committee, as well as the Joint Operations Oversight Committee for Clinical Research, the Research Committees (Main Campus and Medical Center), Shared Resources Oversight Committee as well as the MedStar IRB. Interactions with and cooperation with these offices as well as various Georgetown regulatory committees facilitates Georgetown’s compliance with federal regulations and Georgetown’s internal policies in these areas and ensures that research is done in an ethically compliant manner and that the safety and welfare of human subjects are protected. Where appropriate, the Senior Director also interacts with representatives of government oversight agencies.

Compliance Oversight

• Implement and oversee Georgetown’s new Research Security Program, working closely with other campus offices to ensure compliance with NSPM-33 and the Chips & Science Act, monitor policy updates and ensure that Georgetown’s resulting policies, procedures, trainings, and briefings comply with the new requirements while delivered efficiently and timely to researchers and ensure that relevant documentation associated with foreign travel compliance and the Academic Visitor’s Policy is retained for audit purposes.
• Serve as a primary partner with other Georgetown offices in evaluating and updating Georgetown’s data management policies and procedures, analyzing and filling gaps, and providing training and assistance, as needed.
• Work with UIS to develop, roll-out and enhance the GU-PASS Outside Professional Activities module for the Medical Center, ensure all relevant disclosures are on file, and review and manage conflicts as needed with the VP for Faculty and Academic Affairs.
• Coordinates and monitors the day-to-day compliance activities of Georgetown’s research community, develops and implements audit, review, and other procedures for the purposes of identifying and investigating research misconduct allegations, non-compliance with Georgetown policies on conflict of interest and export controls and with applicable legal, regulatory, or sponsor requirements.
• Monitors developments and changes in federal and local laws, regulations, and guidance to determine impact on the research community.
• Work in an advisory capacity with Georgetown researchers, research offices, regulatory committees, and other campus conflict of interest officers.
• Assist in the coordination and collection of data required for institutional, federal, or other reporting purposes related to research compliance.
• Works with relevant stakeholders in developing and implementing electronic compliance technologies related to research compliance and research security.

Investigations

• Receives and investigates reports or other evidence of regulatory non-compliance or deviation from University or generally accepted standards of ethical and responsible research.
• Manages research misconduct investigations to include notification of the respondent (accused person) and relevant EVP; collection, maintenance, and storage of evidence; monitoring Research Integrity Committee (“RIC”) proceedings to include ad hoc meetings, interviews with complainants and respondents; serving as the complainant’s and respondent’s point of contact with the RIC; writing Subcommittee Inquiry reports and full RIC reports after the relevant proceeding has been concluded; notification of relevant parties of conclusion of proceeding; filing relevant reports.
• Investigate and resolve reports of non-compliance with completion of conflict of interest disclosures. Provide support to ORO staff when researchers are delinquent in filing conflict disclosures with either Georgetown or MedStar.

Administration, Liaison, and Services

• Administer all department services in accordance with applicable laws, regulations, and policies as well as standards and criteria established by Georgetown.
• Act as liaison for research compliance activities with MedStar Health and other collaborating institutions, as required.

Engage with and represent Georgetown in relevant professional and governmental groups or organizations to maintain strong relationships. Acts as Georgetown’s liaison and resource with various local, regional, and national professional organizations and, on committees, to ensure regulatory compliance and research integrity.

Education

• Develops, reviews, and occasionally deliver, in conjunction with other appropriate offices, compliance education and training programs and material for all Georgetown research personnel, e.g., faculty, staff, postdocs, students, related to research misconduct, export controls, research security, conflict of interest and/or conflict of commitment, data management, etc.
• Develops and maintains materials to communicate research requirements and best practices including website updates and electronic educational materials.
• Participates in orientation programs for faculty, staff, and students regarding research compliance.
• Responds to inquiries from faculty, staff, and students related to research compliance.

Additional Duties

• Assumes other duties and responsibilities appropriate to position
• Above duties do not reflect the full scope of the position and are not all-inclusive of the expectations. Some may be delegated as the position will provide oversight but retain responsibility for the execution.

Requirements and Qualifications

Required:

Master’s degree or higher in science or social science or a JD;

Minimum of eight years of relevant experience;

Knowledge, experience and demonstrated skill in interpreting regulations governing research involving human subjects and animal subjects;

Deep understanding of legal, ethical, and compliance issues, and familiarity with medical and scientific principles;

Familiarity with a University or health care setting;

Excellent communication skills and 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 including laws, regulations, and guidance relating to sponsored research, such as the Code of Federal Regulations, Uniform Guidance, Federal Acquisition Regulations, Office for Human Research Protections guidance, NSF and PHS conflict of interest and the PHS Research Misconduct Policy, data management policies, and export controls and trade compliance regulations e.g., Export Administration Regulations, International Trafficking in Arms Regulations, Office of Foreign Assets Control Regulations;

Familiarity with the review and negotiation of sponsored project agreements;

Experience with the federal regulations governing data management and HIPAA compliance; and

Experience with the regulatory requirements related to Responsible Conduct of Research.