Research Integrity Program Manager

Overview

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The Research Integrity Program Manager is responsible for the day-to-day management and oversight of the Conflict of Interest program for Fred Hutchinson Cancer Research Center to ensure compliance with Federal and state regulations and institutional policies related to Conflicts of Interest. The Program Manager serves as the administrative program head, as well as Fred Hutch’s subject matter expert and adviser to senior leadership on all matters related to Conflict of Interest regulations, policies, procedures, and best practices. The Program Manager also oversees the management and coordination of additional policies & procedures related to research integrity and faculty affairs.

Responsibilities

• Manage and coordinate the annual and ongoing COI reporting processes, following up with faculty, staff, and executive leadership as necessary.
• Identify documents for review, conduct research, and conduct faculty and staff interviews as necessary to determine the relevant facts and circumstances related to assigned disclosures. Complete the initial review, analysis, and summary of data and documentation for COI submissions, including collection and review of related supplemental documents describing intellectual property and/or licensing agreements, human research protocols, study-specific documentation, and coordinate with various stakeholders, including the Institutional Review Office, Office of General Counsel, Business Development and Strategy, Office of Sponsored Projects, and Divisional Senior Operations Directors.
• Coordinate with the Conflict of Interest Review Committee, the Vice President for Research Administration and Faculty Affairs, the Senior Vice Presidents/Division Directors, and/or the Deputy Director to develop and implement conflict management plans.
• Provide content expertise, coordination, and support to Fred Hutch’s Conflict of Interest Review Committee meetings. Attend COIRC meetings, present cases, and draft management plans based on COIRC recommendations.
• Manage the online COI reporting system and coordinate with Center IT, Division administrators and others regarding system implementation, maintenance, updates and reporting; track, review and monitor open cases.
• Develop and provide training and education for Scientific Staff regarding COI issues and applicable laws, regulations, policies and procedures.
• Educate clinical faculty about the Physician Payments Sunshine Act/Open Payments requirements; coordinate with the Clinical Research Division to assist clinicians with the CMS annual review and dispute process.
• Manage and coordinate responses to inquiries and activities; develop and maintain COI policies, guidance, procedures.
• Conduct annual monitoring of management plan compliance.
• Support the Vice President, Research Administration and Faculty Affairs with the performance of other duties, as requested, including the coordination of additional policies & procedures related to research integrity and faculty affairs.
• Understand and maintain familiarity with federal, state, and Fred Hutch regulations and policies governing conflicts of interest. Conduct campus-wide education and training in these areas.
• Serve on other institutional compliance committees and work groups as necessary.

Qualifications

Required qualifications:

• Bachelor's degree or equivalent
• Minimum seven years of experience in healthcare compliance, research compliance, or research administration, with regulatory compliance experience
• Excellent interpersonal, oral, and written communication skills
• Must be highly detail-oriented and organized with intermediate knowledge of Microsoft Word, Excel, Outlook, PowerPoint, and SharePoint
• Demonstrated capacity to manage highly sensitive and strictly confidential material
• Experience understanding complex regulations and applying them in a research and/or academic setting.
• Experience working with research and/or university faculty and staff.
• Experience in data analytics, data visualization.
• Ability to solve complicated, sensitive, confidential issues quickly in a fast-paced environment
• Self-starter, able to work under minimal supervision
• Thorough understanding of the goals and mission of Fred Hutch

Preferred qualifications:

• Master’s Degree in an appropriate area and three years of relevant experience, or Juris Doctorate degree and two years of relevant experience
• Program Management experience
• Certified in Healthcare or Research Compliance

Our Commitment to Diversity

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at escmail@fredhutch.org or by calling 206-667-4700.