Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance

  • Research Regulatory Coordinator II

    Job ID
    12351
    Type
    Regular Full-Time
    Company
    Seattle Cancer Care Alliance
    Location
    US-WA-Seattle
  • Overview

    The Seattle Cancer Care Alliance (SCCA), located in Seattle, Washington, is part of a dynamic collaboration among three organizations known nationally and internationally for their patient care and research: Fred Hutchinson Cancer Research Center, University of Washington, and Seattle Children's. Over the past 25 years, these institutions have worked together to support their mission of adult and pediatric oncology patient care services, research and education.

     

    The Research Regulatory Coordinator is responsible for overseeing the day-to-day regulatory management of clinical research trials, which include phases I-IV industry, investigator-initiated, and NIH sponsored research studies, and other research projects offered through Research Integration (RI). The role is responsible for ensuring that all such clinical research activity meets regulatory requirements and is compliant with all federal, state, local and institutional policies. The position will manage study start-up, modification submissions, annual/continuous reporting, and study closeout submissions to the Institutional Review Board (IRB) and any other relevant regulatory agencies, committees, the sponsor, funding foundation or governmental agency. Preparation, submission, and maintenance of the regulatory data will require compliance with complex regulations, policies, and procedures regarding the conduct of clinical trials. This is critical for ensuring patient safety, quality of the research and the reputation of the institution. The Research Regulatory Coordinator serves as a liaison to administrative and clinical staff and must serve as a role model as they promote the mission, values, and philosophy of the Seattle Cancer Care Alliance as they perform their duties.

     

    This position reports to the Regulatory Affairs Manager of Research Integration and must maintain effective working relationships with investigators, management and research staff (both internal and external to the organization).

    Responsibilities

    Regulatory/Essential Documents

    • Understanding of Food and Drug Administration (FDA), International Conference on Harmonization (ICH), Code of Federal Regulations (CFR), and Good Clinical Practice (GCP) policies and guidelines as they relate to the conduct of human clinical trials.
    • Understanding of the research protocols and the ability to translate research requirements into appropriate regulatory actions.
    • Preparation, maintenance and continual oversight of all SCCA RI research-related regulatory documents, which includes, but may not be limited to, the following:
      • Coordinating and managing the regulatory documents from each participating Network Affiliate member institution, from each SCCA Community site location and from Fred Hutch/UW Cancer Consortium Disease Site Research Programs and service areas which are partnering with Research Integration to conduct clinical trials.
      • Creating and maintaining up to date regulatory documents and files at all times. Such files include, but may not be limited to, NCTN study documentation, DOA logs, Curriculum Vitae (CVs), Medical Licenses (MLs), HSP and GCP training documentation, protocol-specific training documentation, conflict of interest (COI) and financial disclosure (FD) documents, etc.
      • Assisting in the development and maintenance of, and adherence to, SCCA RI’s Standard Operating Procedures (SOPs) and Work Instructions.
      • Maintaining all regulatory documentation, site documents and study regulatory files, ensuring that all documentation is compliant with all applicable SOPs and are in audit-ready condition (i.e., up to date, accurate and complete at all times).
      • Archiving clinical trial documents/records, ensuring that all regulatory files are prepared for off-site storage in accordance with FDA, other applicable regulatory guidelines and RI SOPs.
      • Coordinating and negotiating with study sponsors regarding the development and modification of consent form language; write clinical research trial consent forms in accordance with GCP and FDA guidelines; translate complicated research protocol requirements into language easily understood by research participants and laypersons.
      • Understanding of and the ability to perform the administrative requirements of clinical research projects.
    • Management of clinical research regulatory information in the Clinical Trial Management System (CTMS).
    • Management of record retention, archiving, and document destruction of clinical trial records, ensuring that all essential documents are handled in accordance with FDA, other applicable regulatory guidelines and SOPs.

    IRB Coordination

    • Preparation of all submissions and query responses in a timely manner to the Institutional Review Board (IRB) to assure the protection of human subjects in research; FDA-required submissions which may include investigator 1572 forms, safety reports, and other documents that may be required by a regulatory agency or the institution. All submissions must be reviewed by the Principal Investigator (PI), be complete and accurate, and transmitted to the appropriate authority in a timely manner to meet all deadlines.
    • Completion of study start-up regulatory activities, ongoing IRB continuing reviews, modifications and study closeout regulatory documents with submissions to all appropriate committees and authorities. All submissions must be reviewed by the PI, be complete and accurate and be transmitted to the appropriate authority in a timely manner to meet all deadlines.
    • Effective communication regarding sponsor (and other committees as appropriate) queries based on regulatory submissions. Ability to determine when documentation needs to be reviewed/approved by PI. All submissions must be reviewed by the PI (if applicable), be complete and accurate, and be transmitted to the appropriate authority in a timely manner to meet all deadlines.
    • Management, communication and documentation of all non-compliance/deviation reports, SAEs and 3rd Party Safety Reports, ensuring that the IRB Reporting Policy is adhered to at all times. Ability to determine if information needs to be reported to the IRB, sponsor, FDA, or other regulatory authorities and whether expedited reporting criteria have been met.

    Inspections/Audits/Monitoring Visits

    • Preparation for internal and external inspections, audits and monitoring visits by collaborating with the QA Specialist and clinical research coordinators to prepare regulatory binders and documents; and, confirming the accuracy of the content of the regulatory binders prior to monitoring visits.
    • Coordination and scheduling of the monitoring visit and communicating with the monitor during their visits.
    • Collaboration with the QA Specialist and study coordinators to ensure completion of follow-up action items.

    Qualifications

    Required:

    • Bachelor’s degree or equivalent professional experience
    • A minimum of 3 years relevant experience in oncology quality assurance, regulatory affairs, or clinical research/study coordination function

    Desired:

    • Knowledge of Seattle Cancer Care Alliance/University of Washington/Fred Hutchinson Cancer Research Center regulatory processes
    • Experience with WIRB

    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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