Compliance Officer, Research Integrity and Conflict of Interest - Washington, United States - George Washington University

Description

I. JOB OVERVIEW

Job Description Summary:

The George Washington University is committed to promoting the highest standards of ethical research and scholarly conduct while pursuing its research mission. The Office of Responsible Conduct of Research (RCR) within the Office of Research Integrity and Compliance (ORIC) promotes research integrity and responsible conduct of research throughout the University.

Serving as the Research COI Administrator and Deputy Research Integrity Officer (D-RIO), the Compliance Officer, Research Integrity & Conflict of Interest will:

• Lead research-related Conflict of Interest and Commitment (COI/C) and Responsible Conduct of Research (RCR) functions across GW;
• Promote integrity in these areas through: the development and delivery of targeted strategic communications, education and training; assisting GW's Research Integrity Officer (RIO) in the handling of complaints, allegations and proceedings in keeping with GW policies and federal regulations; oversight and tracking of compliance with applicable federal and sponsor requirements, and the development and maintenance of processes and procedures to support GW scholars and investigators in understanding their ethical and fiduciary responsibilities with respect to research activities;
• Lead the University's research COI/C programs, in collaboration with the University Office of Ethics, Compliance and Risk (OECR), the Office of Sponsored Projects (OSP), the Office of Human Research (OHR), the GW Export Control Officer, and other relevant institutional offices, schools and departments;
• Serve as a first point-of-contact for covered investigators seeking assistance in submitting disclosures or COI/C-related policy guidance;
• Interpret rules and regulations covering COI/C related to research and develop policies and procedures in accordance with GW process related to COI/C;
• Develop, manage, and maintain the COI/C program for research, including training and mentoring for GW research community; ensure program meets federal funding requirements as well as applicable state and federal requirements;
• Manage processing and review of submitted disclosures. Obtain additional information from covered individuals when necessary and refer disclosures requiring additional review or management to the COI Committee(s), as applicable;
• Administer the COI Committee(s): prepare disclosures or other matters for review, schedule meetings, prepare agendas and materials, and draft meeting minutes, determination letters and/or management plans, as applicable;
• In coordination with GW's Technology Commercialization Office, assist with the evaluation of faculty start-ups and management of conflicts of interests related to licensed technology and other intellectual property;
• Collaborate with colleagues within and outside ORIC on GW, Medical Faculty Associates (MFA), and/or GW University Hospital research-related COI/C policies, as appropriate;
• Provide analytical, logistical, and organizational support for GW's research integrity program;
• Serve as a first point-of-contact for investigators, scholars, and other research stakeholders seeking consultation on concerns related to possible research misconduct; work with faculty, staff, and students to promote a culture of ethical and responsible conduct of research;
• In consultation with the RIO, coordinate and support research misconduct proceedings, including initial assessment of allegations, inquiries and investigations in accordance with relevant regulations and policies. This may include but is not limited to assisting with the following: draft and provide notification; convene subject matter expert panels and assist with scheduling meetings; sequester, secure, and maintain chain of custody of research records; prepare required reports, analyze issues and develop materials to facilitate the review of allegations in research misconduct proceedings; prepare and send formal communications and memoranda; maintain a secure, password protected storage system for all documents and material related to research misconduct proceedings; maintain tracking information for all research misconduct allegations and related research misconduct proceedings to ensure compliance with regulatory requirements and timely completion of proceedings; communicate with federal agency officials as appropriate, and prepare GW's annual report and assurance to the Department of Health and Human Services Office of Research Integrity and other relevant agencies;
• Maintain auditable records of all relevant documents pertaining to areas of oversight;
• Collaborate with GW IT to refine and update existing databases and workflow products and identify new information technology resources as appropriate;
• Continually evaluate and develop procedures and operations in order to ensure effective service delivery and compliance with relevant policies related to areas of oversight;
• In collaboration with ORIC leadership, consult with federal regulatory agencies regarding individual cases to ensure institutional compliance with applicable regulations;
• Develop relationships with various internal groups to identify avenues for promotion of research integrity;
• Assist the Compliance Officer, Research Compliance and Quality Assurance (RCQA) and other stakeholders with routine auditing activities involving COI management plans, publications, foreign relationships and components, export control compliance, data archival and availability, funded projects, disclosure accuracy, and other audit schedules as identified;
• Participate in relevant national organizations and training; maintain an expert level knowledge and interest in the institutional, local, and national environments related to areas of oversight, including faculty entrepreneurship, undue foreign influence, and clinical research-related regulatory matters.

The position requires:

• Strong critical thinking skills and the ability to analyze, summarize, and effectively present information in both summary and in-depth forms.
• Good working knowledge of research compliance areas and applicable regulatory frameworks (i.e., Conflict of Interest/Commitment, organizational conflicts of interest, institutional conflicts of interest, Responsible Conduct of Research, Data Management, Foreign Influence, research misconduct procedures, etc.).
• Ability to use discretion and independent judgment to manage, protect and impart confidential information in a secure manner.
• Demonstrated excellence in organizational skills, attention to detail, and ability to set appropriate priorities between multiple concurrent tasks.
• Strong interpersonal and oral/written communication skills, as well as diplomacy, equipoise, and a high level of professionalism.
• Ability to teach and create effective training programs for diverse audiences, including appropriate references to GW's own policies, documentation, templates, and other relevant resources on research ethics, integrity, and compliance.
• Ability to work well under pressure when necessary and to respect and reconcile different points of view.
• Ability to perform complex as well as routine tasks.
• Consistent monitoring of the regulatory landscape to ensure compliance with evolving local, state, and federal guidelines and regulations, analyzing potential effects on the institution as well as faculty, staff, or students.
• Familiarity with Huron or other electronic research administration platforms.
• Superior computer skills to develop reports, maintain and secure data, create special presentations, and electronic retrieval and/or submission of agency-generated compliance materials.
• Ability to assist with other research compliance areas as needed.

Performs other related duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.

Minimum Qualifications:

Qualified candidates will hold a Bachelor's degree in an appropriate area of specialization plus 7 years of relevant professional experience, or, a Master's degree or higher in a relevant area of study plus 5 years of relevant professional experience. Degree must be conferred by the start date of the position. Degree requirements may be substituted with an equivalent combination of education, training and experience.

Additional Required Licenses/Certifications/Posting Specific Minimum Qualifications:

Preferred Qualifications:

• Master's degree or Law degree preferred.
• Five years of directly related professional experience in research compliance within a higher education, nonprofit, or academic setting preferred.
• Compliance certifications preferred.
• Bachelor's degree in the sciences (hard science, social/behavioral sciences) or similar major desired.
• Strong critical thinking skills and the ability to analyze, summarize, and effectively present data.

Typical Hiring Range

Commensurate with Experience.

II. JOB DETAILS

Campus Location:

Foggy Bottom, Washington, D.C.

College/School/Department:

Office Vice President of Research (OVPR)

Family

Research Administration

Sub-Family

Research Compliance

Stream

Individual Contributor

Level

Level 4

Full-Time/Part-Time:

Full-Time

Hours Per Week:

40

Work Schedule:

Monday through Friday, 8:30am-5:00pm

Will this job require the employee to work on site?

Yes

Employee Onsite Status

Hybrid

Telework:

Yes

Required Background Check:

Criminal History Screening, Education/Degree/Certifications Verification, Social Security Number Trace, and Sex Offender Registry Search

Special Instructions to Applicants:

• Employer will not sponsor for employment Visa status
• Please include hours worked per week for each position on your resume

Internal Applicants Only?

No

Posting Number:

S012998

Job Open Date:

05/01/2024

Job Close Date:

If temporary, grant funded or limited term appointment, position funded until:

Background Screening

Successful Completion of a Background Screening will be required as a condition of hire.

EEO Statement:

The university is an Equal Employment Opportunity/Affirmative Action employer that does not unlawfully discriminate in any of its programs or activities on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity or expression, or on any other basis prohibited by applicable law.