• Regulatory Coordinator II- Clinical Trials

    Job ID
    14184
    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.


    The Cancer Immunotherapy Trials Network is a National Cancer Institute (NCI) sponsored network tasked to stimulate the conduct of early Phase I and Phase II clinical trials in the area of cancer immunotherapy. The goals are to establish a productive network of leading investigators and institutions to implement early phase cancer immunotherapy trials, design and conduct novel biologically dictated early phase trials using agents and combinations of agents to demonstrate proof-of-concept essential to proceed to Phase III pivotal trials, and provide high quality immunogenicity and biomarker data that elucidate mechanisms of response.


    The network is coordinated through a Central Operations and Statistical Center (COSC), which is housed at Fred Hutchinson Cancer Research Center. The Network is supported by an NCI grant and a commitment of substantial NCI services augmented by Fred Hutchinson Cancer Research Center institutional funds as well as industry and foundation funding.


    We are seeking an energetic individual with a background in clinical research for the position of Regulatory Affairs Coordinator.

    Responsibilities

    The incumbent works with the Senior Regulatory Affairs Associate to ensure regulatory compliance within the CITN COSC and affiliate network and at participating clinical research sites. Job duties include:

    • Serve as regulatory support liaison for interdepartmental and external agencies including, but not limited to Cancer Treatment Evaluation Program (CTEP), Office for Human Research Protections (OHRP), Regulatory Affairs Branch (RAB), Food and Drug Administration (FDA), the Fred Hutchinson Cancer Research Center’s Institutional Review Office, NCI Central IRB, and participating CITN site IRBs
    • In conjunction with Cancer Immunotherapy Trials Network (CITN) Sr. Regulatory Affairs Associate and Clinical Trial Managers, facilitate and track trial protocols through all applicable review and approval processes including, but not limited to CTEP, FDA, IRBs, RAB, and in-country agencies
    • Assist in ensuring that participating CITN research sites have complied with all applicable regulatory requirements of the site registration process.
    • Assists the Sr. Regulatory Affairs Associate in regulatory oversight on safety reporting for the CITN and CITN affiliate network
    • Assist in compiling materials needed for investigational new drug (IND) submissions, IND safety reports and annual reports as required
    • Contribute to the design, development and implementation of SOPs that ensures the CITN COSC conducts its regulatory activities in accordance with FDA/ICH regulations and guidance documents
    • Assist in preparing and submitting regulatory documents
    • Perform document filing and retrieval as directed
    • Contribute to departmental process improvements which impact Regulatory Affairs
    • Assist the Sr. Regulatory Affairs Associate in monitoring, interpreting and validating current and changing regulatory legislation and instructional polices, and ensure new regulations or changes to existing regulations are communicated throughout the CITN COSC sharing potential impacts these changes may have on ongoing protocols
    • Assist the Sr. Regulatory Affairs Associate in managing sites who utilize the Fred Hutch IRB as the IRB of Record
    • Assist the Sr. Regulatory Affairs Associate in providing review of non-lead IRB sites consent forms and other applicable regulatory documents
    • Coordinate with others, as appropriate, to resolve highly complex or extraordinary regulatory problems that may arise seeking assistance from appropriate internal and external resources
    • Work to develop and acquire required regulatory skills and knowledge with guidance from Sr. Regulatory Affairs Associate
    • Identify potential regulatory risks to the operational plans of the CITN COSC, and propose options to mitigate risks
    • Assist in monitoring government websites for misconduct by investigators in clinical trials
    • Additional and incidental duties related to the primary job duties described above may be required for successful execution of job performance.

    Qualifications

    • Minimum BS in Life Sciences, advanced degree preferred
    • 2-3 years of experience working within the human research regulatory environment
    • Current working knowledge of FDA regulations as it pertains to human research, GCP, and International Council for Harmonisation guidelines
    • Knowledge of clinical trial safety issues
    • Excellent interpersonal skills and attention to detail
    • Experience interacting with clinical sites regarding regulatory compliance as it pertains to human clinical research

    Note: Some travel may be required for this position

    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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