Manager, Research Integrity and Conflict of Interest

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Job Description Summary:

Job Code: 2648
Job Profile Name: Advisor - Research Integrity and Conflict of Interest
JOB SUMMARY
The Manager - Research Integrity and Conflict of Interest will oversee the research conflict-of-interest compliance program for OhioHealth. In support of OhioHealth Research Institute, the manager will draft management plans, update policies, track and review disclosures, and identify potential improvements. The Advisor will work closely with OhioHealth’s Ethics & Compliance Office, Office of Human Subject Protections, Research Operations and the IRB to serve as a COI subject matter expert. This position will assist OhioHealth leadership in conducting workplace investigations into alleged conflicts of interest related to research, developing and delivering training sessions as needed to reduce risk throughout OhioHealth. Other compliance-related duties as assigned, potentially including but not limited to workplace investigations of compliance matters beyond conflict of interest, analysis of third-party compliance risk, compliance program assessments, and/or policy program management.

Minimum Qualifications:

Bachelor's Degree: Clinical Research (Required)

JOB SUMMARY
The Manager - Research Integrity and Conflict of Interest will oversee the research conflict-of-interest compliance program for OhioHealth. In support of OhioHealth Research Institute, the manager will draft management plans, update policies, track and review disclosures, and identify potential improvements. The Advisor will work closely with OhioHealth’s Ethics & Compliance Office, Office of Human Subject Protections, Research Operations and the IRB to serve as a COI subject matter expert. This position will assist OhioHealth leadership in conducting workplace investigations into alleged conflicts of interest related to research, developing and delivering training sessions as needed to reduce risk throughout OhioHealth. Other compliance-related duties as assigned, potentially including but not limited to workplace investigations of compliance matters beyond conflict of interest, analysis of third-party compliance risk, compliance program assessments, and/or policy program management.

RESPONSIBILITIES AND DUTIES

Leads the research conflict of interest and compliance program.

• Promotes research integrity through: the development and delivery of targeted strategic communications, education and training; assisting the ethics and compliance program in the handling of complaints, allegations and proceedings in accordance with institutional 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 OhioHealth researchers and investigators in understanding their ethical and fiduciary responsibilities with respect to research activities.
• Manages the annual and ongoing conflict of interest reporting processes, including data collection for the IRS Form 990, and follows up with disclosers, as needed.
• Managing the daily research conflict-of-interest compliance program, leads the research conflict of interest review committee meetings, and tracks and analyzes metrics/trends for the program. 
• Reviews and analyzes employee personal and financial disclosures for potential conflicts of interest related to research. Investigates alleged violations of the research conflict-of-interest policy.
• Ensures appropriate federal reporting of conflicts of interests, tracks compliance with management plans, oversees review of and response to information compiled by CMS under the Physician Payments Sunshine Act.
• Serve as the point-of-contact for investigators on research conflict of interest/compliance related policy guidance and/or seeking assistance in submitting disclosures.
• Managing and serves as a subject-matter expert for institutional compliance, such as workplace investigations of compliance matters beyond conflict of interest, analysis of third-party compliance risk, compliance program assessments, and/or policy program management.
• Manages the online conflict of interest reporting system and coordinates with IT, Research Operations and others regarding system updates and reporting, and regularly tracks the conflict-of-interest online system, including review and disposition of open issues.
• Interprets laws, guidance and regulatory changes governing research and determines applicability to OhioHealth research.
• Develops and delivers training, both online and in-person, on research conflicts of interest. Serves as a resource and subject matter expert to physicians, staff and leadership.
• Assists with needed training updates. Develops and implements specific improvements as needed.
• Works with varied stakeholders and departments (e.g., Office of General Counsel, OHRI Research Operations, Office of Human Subjects Protections) to reduce risk.
• Assists senior leadership with institutional efforts to reduce third-party risk.
• Collaborates with business partners to develop, implement, and evaluate compliance guidance for internal/external processes.
• Partners with the Office of the General Counsel to review and interpret complex regulations before clearly communicating them to stakeholders.
• Develops and drafts management plans to mitigate conflicts of interest related to research. Assists with building a comprehensive program designed to ensure compliance and ethical decision-making across the institution university. Evaluates compliance training and development programs, identifying potential improvements and making recommendations as necessary.
• Researches and identifies trends and best practices related to reducing and/or managing conflicts of interest in research.
• Regularly updates institutional policies, procedures, and the code of ethics. Stays current with changes to laws/regulations which may affect communications and OhioHealth policies.
• Promotes an environment that fosters inclusive relationships and creates unbiased opportunities for contributions through ideas, words, and actions that uphold principles of OhioHealth’s Code of Ethics.
• Advises senior leadership of new regulatory requirements, guidance and other relevant information.
• Builds effective working relationships with executive leadership teams, committees, OhioHealth teams and departments.
• Maintains auditable records of all relevant documents pertaining to areas of oversight.
• Performs other related duties as assigned or requested.

Other

• Attends relevant training courses on policy and compliance.
• Maintain familiarity with evolving regulatory and compliance context. 
• Stay up to date on new rules and procedures.

MINIMUM QUALIFICATIONS

• Bachelor’s degree in clinical research, health related field, legal studies, audit, or similar ethics and compliance education.
• 5+ years of professional experience in research compliance within a higher education, nonprofit, or academic setting; and working with institutional and federal regulatory requirements, policies and codes of conduct.
• Demonstrates an extensive level of proficiency in the following competencies or qualifications: Managing or leading/participating in a work team, Effective communication (written and verbal), the ability to effectively and accurately exchange, transmit, receive and interpret ideas, information and needs with team members through appropriate communication methods.

DESIRED ATTRIBUTES

• Master’s degree in business administration, clinical research, legal studies, finance, or similar research ethics and compliance.
• 10+ years working with regulatory requirements, policies, and codes of conduct.
• Knowledge of Clinical and Regulatory research operations and their impact to workflows.
• Technical capacity to utilize multiple information systems and Microsoft applications, including Excel; and experience with compliance tools and/or systems including REDCap, Cayuse, eReg software and COI-SMART, CMS Open Payments
• Experience working on compliance in higher education, nonprofit and/or academic medical center environments.
• Familiarity with research in a large hospital system a plus.
• Familiarity with Public Health Service regulations and experience in management of conflict-of-interest programs or other research compliance processes
• Knowledge of and experience interpreting and applying federal laws, regulations and guidelines governing research
• Ability to present findings and discuss issues with providers confidently and effectively
• Ability to handle sensitive communications with leadership, legal counsel and regulatory agencies
• Strong attention to detail and highly organized
• Strong interpersonal, analytical and presentation skills
• Strong written and oral communication skills
• Strong team player with ability to work well independently and as a group
• Ability to work under pressure, multi-task and meet deadlines
• Research, compliance or other related certification highly preferred

BEHAVIORAL COMPENTENCIES

LEADERSHIP COMPETENCIES

INFORMATION SECURITY
Maintains confidentiality of log-on password(s) and security of other authentication devices (e.g., key fobs, proximity devices, etc.).
Ensures privacy and security of information entrusted to their care.
Uses company business assets and information resources for management-approved purposes only.
Adheres to all information privacy and security policies, procedures, standards, and guidelines.
Promptly reports information security incidents to the OhioHealth Information Security Officer.

Work Shift:

Day

Scheduled Weekly Hours :

40

Department

Research Administration

Join us!
... if your passion is to work in a caring environment
... if you believe that learning is a life-long process
... if you strive for excellence and want to be among the best in the healthcare industry

Equal Employment Opportunity

OhioHealth is an equal opportunity employer and fully supports and maintains compliance with all state, federal, and local regulations. OhioHealth does not discriminate against associates or applicants because of race, color, genetic information, religion, sex, sexual orientation, gender identity or expression, age, ancestry, national origin, veteran status, military status, pregnancy, disability, marital status, familial status, or other characteristics protected by law. Equal employment is extended to all person in all aspects of the associate-employer relationship including recruitment, hiring, training, promotion, transfer, compensation, discipline, reduction in staff, termination, assignment of benefits, and any other term or condition of employment