• Regulatory Affairs and Quality Assurance Manager

    Job ID
    12383
    Type
    Regular Full-Time
    Company
    Fred Hutchinson Cancer Research Center
    Location
    US-WA-Seattle
    Category
    Clinical Research Support Services
  • 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.

     

    Fred Hutch Global Oncology (GO), a cross-divisional program overseen by the  Office of the President at Fred Hutchinson Cancer Research Center, has a mission to generate cancer research that has global impact, and support the development of research capacity and clinical care to reduce the cancer burden in low- and middle-income countries. A cornerstone of the program is a decade-long alliance with the Uganda Cancer Institute (UCI) that advances research, capacity building, and cancer care in Uganda. Fred Hutch operates in Uganda as the Hutchinson Centre Research Institute of Uganda.

     

    This Seattle-based position is responsible for regulatory and quality assurance oversight of all international studies conducted with the global oncology program and supervising 3 international staff. The incumbent will work with the Fred Hutchinson Institutional Review Office (IRO) and the Office of General Counsel in consultation on regulatory compliance issues. The incumbent provides human subjects protection knowledge and expertise to help facilitate ethical review and ensure regulatory compliance within Fred Hutch and at participating global oncology sites. The position reports to the Managing Director, with dotted line to the Fred Hutch Global Oncology Deputy Head.

    Responsibilities

    Regulatory Affairs

    • Supervise the regulatory staff in Uganda, overseeing their performance and professional development to advance the program’s research
    • Perform regulatory review and assist in writing of study documents (e.g., protocol, ICFs, etc) during protocol development.
    • Prepare regulatory documents for submission (new study, continuation, modification, serious adverse event, and study closure) to all applicable regulatory bodies. 
    • Manage the protocol activation process and track the required documents and activities needed for protocol activation. Perform review of documents for completeness and accuracy. Distribute protocol activation communications allowing enrollment to start once regulatory documents are in place.
    • Ensure the accurate translation of informed consent forms process by working with the translation companies to obtain translations of informed consent forms in the desired language in a timely manner.
    • Liaise with Fred Hutch Office of General Counsel and/or the Office of Tech Transfer, as well as the collaborating/partnering organization(s), in order to create data and material transfer and use agreements (DMTUA) between international and domestic partners.
    • Update the master Material Transfer Agreement (MTA) between the Fred Hutch and the Uganda Cancer Institute, as needed.
    • Maintain and manage IRB approvals and trainings from outside institutions in which we have a DMTUA with to ensure they are in compliance with FHCRC IRB and federal regulations.
    • Manage and maintain approval documentation for ancillary study proposals that require obtaining specimens from the biorepository.
    • Manage the regulatory tracking and archive systems (e.g. SharePoint).
    • Conduct regulatory trainings to study teams on the latest research and ethics regulations as needed. Conduct yearly regulatory overview for new investigators and trainees.
    • Lead monthly meeting with the Uganda Cancer Institute Research Ethics Committee (UCIREC) chair, the UCIREC research administrator, and the Fred Hutch IRO Director to discuss how to address scenarios that may arise in reviewing a study and to maintain capacity building.
    • Provide regulatory oversight on safety reporting for the GO research.
    • Design, develop and implement regulatory standard operating procedures (SOPs) to ensure that GO conducts its regulatory activities in accordance with ICH/GCP regulations and guidance documents, as outlined by study sponsors.
    • Monitor, interpret and validate current and changing regulatory legislation and instructional polices, and ensure new regulations or changes to existing regulations are communicated throughout the GO program, and share potential impact that these changes may have on ongoing protocols.
    • Provide guidance and support to investigators and staff to ensure compliance with local country and US research regulations and policies.
    • Create regulatory process improvements to strengthen the regulatory unit and shorten the IRB time to approval turnaround time.

     

    Quality Assurance

    • Supervise the quality assurance staff in Uganda, overseeing their performance and professional development to advance the program’s research
    • Create and revise all auditing templates.
    • Conduct and/or oversee the internal monitoring of all open trials.
    • Review and approve all internal audit reports prior to distributing the findings to the study team.
    • Develop study specific quality management plans.
    • Create yearly internal auditing schedule.
    • Review and approve all Standard Operations Procedures (SOPs) and study specific procedures (SSPs).
    • Manage the quality assurance tracking system, which houses the SOPs, SSPs, protocol deviations, and internal quality reports.
    • Train the regulatory and quality assurance team.
    • Create process improvements to strengthen the quality assurance unit.
    • Provide guidance to investigators and staff to ensure the study is being conducted as outlined in the latest institutional review board (IRB) approved protocol.

    General Research Administration

    • Contributes to development of site standard operating procedures.
    • Contributes to development of program quality management systems.
    • Contributes to development of GO program communication and document storing and sharing tools (e.g., SharePoint).
    • Contributes to GO program reports (e.g., monitoring and evaluation report, research status report, insurance renewal reports, etc.).

    Qualifications

    Required qualifications:

    • Minimum Bachelor’s Degree, advanced degree in relevant discipline preferred.
    • Minimum of 7years of experience working within regulatory, including research that is implemented internationally in developing countries.
    • Minimum of 3 years of quality assurance experience
    • 1-3 years' experience managing high-functioning team
    • Knowledge of FDA regulations, clinical trial safety issues, GCP/ICH and IRB guidelines.
    • High level of attention to detail, organizational skills, and a commitment to accuracy.
    • Strong verbal and written communications skills.
    • Self-motivated and able to work independently using strong organizational and time management skills.
    • Strong interpersonal skills.
    • Ability to solve problems and work independently, as well as provide guidance and leadership among peers on a team.
    • Willingness to travel internationally at approximately 15% a year.

     

    In addition to the required qualifications, the ideal candidate will have the following characteristics:

    • Comfortable working in a fast-paced environment.
    • Experience working with international partners across time zones.
    • Experience working for an IRB/IRO, or serving as an IRB member.

    Our Commitment to Diversity

    We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, 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.

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