Conflict of Interest Program Manager

City of Hope

(Duarte, California)
Full Time
Job Posting Details
About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 4000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.

Summary

The Conflict of Interest ("COI") Manager is responsible for day to day management of the conflict of interest processes for City of Hope, including City of Hope National Medical Center, City of Hope Medical Foundation, City of Hope Beckman Research Institute, and the City of Hope Development Group, (collectively, "City of Hope") The Conflict of Interest ("COI") Manager is responsible for managing and overseeing the research conflict of interest processes, including, management of the online COI system and database; coordination and administrative leadership of Conflict of Interest and Commitment Committee ("COICC") meetings; maintenance of records documenting COICC activity; and tracking follow-up and compliance. The COI Manager also oversees City of Hope's annual and ongoing COI disclosure process for Director level and above employees, as well as Medical Staff and Board of Directors, and the process for identifying and managing institutional conflicts of interest. Additionally, the COI Manager tracks related regulatory updates and industry best practices, drafts and updates COI policies and procedures and guidelines, and coordinates training and education about COI policies and the development and maintenance of COI policies and procedures.

Responsibilities
  • Serves as City of Hope subject matter expert on regulations and guidance relating to conflict of interest, and on City of Hope conflict of interest and commitment policies.
  • Manages and coordinates the annual and ongoing COC/COI reporting processes, including data collection for the IRS Form 990, and follows up for compliance and clarity, as needed.
  • Assists reviewers with the conflict of commitment review and approval process.
  • Serves as resource for questions concerning the interpretation of policies and their application to individual circumstances and assists Covered Persons in the disclosure process. This includes coordination with BRI faculty, Physician researchers, members of regulatory research and other committees, Director level employees and above, Medical Staff, Community Members, and members of Board of Directors and Board Committees.
  • Serves as senior level administrative support person for the COICC, including, coordination of the annual review calendar, meetings, minutes, materials, reports, and agendas. Attends COICC meetings, presents Covered Persons COI disclosures and related background information to the Committee, and drafts follow up materials, as directed. Facilitates new COICC member appointments and orientation.
  • Completes initial review, analysis and summary of data and documentation for all COC/COI submissions, including collection and review of related supplemental documents describing intellectual property and/or licensing agreements, human subject protocols, study-specific forms, project data and approval forms, and/or consulting agreements, including coordination with research regulatory committees and researchers, as required.
  • Coordinates with the Office of Technology and Licensing, the Office of Sponsored Research, Covered Persons and other City of Hope Departments and executives, as necessary, to compile relevant information to manage Covered Persons’ disclosures and make recommendations for conflict management to the COICC. Processes all requests that qualify for administrative or expedited review via iRIS.
  • Works with management and COICC, as applicable, to track the compliance with COI management plans.
  • Serves as manager for the iRIS COI online system. Coordinates with Senior Systems Specialist, Clinical Research Operations regarding system updates, and generates reports as requested.
  • Regularly tracks and monitors iRIS COI online system, including daily review of open issues and submissions.
  • Ensures coordination between the disclosures on COI Annual Reporting Forms and other covered Person COI disclosure forms, including research sponsor or IRB forms.
  • Develops, provides and coordinates training and education for Covered Persons and graduate students regarding COI issues and applicable federal and state laws and COH policies, including administration of the COI training program for PHS-funded Investigators.
  • Manages and coordinates other required inquiries and activities relating to conflict of interest disclosure and management at City of Hope.
  • Develops and maintains COI-related policies and procedures and guidelines, including ongoing monitoring of compliance with policies.
  • Works with Deputy General Counsel to coordinate legal review of contracts and agreements for COH Covered Persons.
  • Works with OSR and OIDRA to ensure appropriate federal reporting of conflicts of interest is performed.
  • Participates in Internal Audits of organizational processes that are related to the COI management.
  • Supports Chief Risk Officer and Compliance Officer, Medical Center and Beckman Research Institute, and Chair COICC/Institutional Official with performance of other duties as requested.
Ideal Candidate
  • At least five (5) years’ experience in healthcare compliance or research operations with regulatory compliance experience.
  • Masters Degree or J.D. may substitute for years of experience.
  • Experience in management of research conflict of interest program preferred.
  • General knowledge of research compliance and federal conflict of interest guidelines, required.
  • Working knowledge of Public Health Services, National Science Foundation and Food and Drug Administration regulations and published standards for conflicts of interest, preferred.

Questions

There are no answered questions, sign up or login to ask a question

sign up or login to save this job and more
Duarte, California
Skills Desired
Sign up or login to see how your skills match up.
  • Audits
  • Consulting
  • Data Collection
  • Documentation
  • Licensing
  • State Laws
  • Subject Matter Expert
  • Health Services
  • Public Health
  • Clinical

Want to see jobs that are matched to you?

DreamHire recommends you jobs that fit your
skills, experiences, career goals, and more.