• Senior Project Manager, Clinical Trials/Clinical Research Compliance

    Job ID
    14604
    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.


    We seek a Senior Project Manager with strong clinical research knowledge/background, audit coordination and facilitation skills, and the ability to manage multiple projects for the Infectious Disease Sciences' clinical trials/clinical research compliance activities. This individual reports to the Program Operations Director of the Infectious Disease Sciences (IDS) Program, oversees IRB/Regulatory processes and activities in IDS and serves to enhance our compliance activities in order to support the overall development and growth of the IDS Program’s clinical research contracts and clinical trials.

     

    The role will help drive projects and bring value through activities including research of applicable rules and procedures, managing and monitoring quality systems within the Program, and maintaining a current working knowledge of applicable regulations and standards. The ideal candidate will be responsible for managing the program’s IRB/Regulatory team, developing a deep understanding of Good Clinical Practices, Human Subjects, FDA and NIH processes, reviewing and updating standard operating procedures, coordinating systems audits and audit follow-up, facilitating external inspections and study visits, and monitoring contract milestones and customer service issues.

     

    For more information about the work of Infectious Disease Science, click here: 

    https://www.fredhutch.org/en/research/divisions/vaccine-infectious-disease-division/research/infectious-disease-sciences.html

    Responsibilities

    Compliance, Audits and IRB/Regulatory Team Management and Oversight

    • Manage Program’s IRB/Regulatory staff by facilitating and supporting regulatory, human research protection and related activities in a dynamic clinical research environment, and by enhancing and applying knowledge of regulatory guidelines (IB, IACUC, MUA, etc.), and knowledge of FDA, GCP and NIH requirements.
    • Be the primary Program lead for Fred Hutch’s CTMS systems.
    • In conjunction and support of the Fiscal team, the various clinical research teams and study PIs, conduct contract reviews and assessments of collaborative and sponsorship activities, work products, and deliverables that includes identification of potential risks and recommendations for mitigation.
    • Help to ensure laboratory and research services are in compliance with study protocols and approved SOPs.
    • Be responsible for internal audits and be the primary contact for sponsor and regulatory agency audits. Lead, prepare and participate in on-site regulatory audits and inspections.
    • Prepare written records of all inspections and audits, including protocol/plan, and SOPs.
    • Have a comprehensive and disciplined approach to risk management and regulatory compliance through an intimate understanding of processes and systems, a network of appropriate contacts, and an in-depth knowledge of the internal operations as well as basic understanding of the requirements and systems of the FDA, other government agencies, and sponsorship organizations.

     

    Clinical trials liaison, contract negotiation and implementation

    • Be the primary Program lead in clinical trials/clinical research contract negotiations.
    • Assist in tracking and managing all contracts through the contract lifecycle, including drafts, modifications, executions, amendments and renewals. Prepare contract briefs to assure proper interpretation of the contract.
    • Manage selected VALUE contracts and assist with close-outs. Disseminate contractual information as appropriate.
    • Facilitate responses to cost/pricing bids for selected clinical trial studies, proposals and contract negotiations including doing initial reviews of contract terms and requirements, to ensure compliance with all laws and regulations and policies and procedures.
    • Audit existing contracts and oversee contract modifications.
    • Coordinate with Business Development and PI teams to provide strategic input on contracting opportunities and assist in the development, population, and maintenance of an in-house contract management system.

     

    Team Support, Communications, Record-keeping

    • Provide staff supervision to the IRB/Regulatory functional team of the IDS Program by planning and overseeing their training, performance, assignment of work and professional development to advance the Program’s regulatory operations.
    • Contribute to a positive and productive work environment through effective collaboration with cross functional units.
    • Proactively develop relationships with, establish goals in collaboration with and have regular touchpoints with key internal stakeholders including clinical, research and business development, Program and PI teams.
    • Work with clinical research study teams, fiscal and lead regulatory staff to ensure timely delivery of contract administration milestones.
    • Develop and support established records management procedures.
    • Assist in the development, maintenance and monitoring of program reports, key performance indicators, forms and templates.
    • Effectively communicate with contracted agencies, partners and stakeholders.

     

    Project Management, Process Improvement

    • Organize and promote Program-wide quality system improvement efforts.
    • Update and review standard operating procedures, work instructions, forms and templates as required.
    • Participate in process improvement activities including assessing current processes, providing improvement input and implementing changes.
    • Work closely with clinical research teams to provide expert compliance and regulatory information, manage identified issues, and support continuous improvement.
    • Manage other related projects as assigned by Program Operations Director.

    Qualifications

    Required

    • Bachelor’s Degree;
    • 5+ years of related experience in human subjects research, contract management/auditing, clinical trial management, project management and/or quality compliance role in the pharmaceutical/biotechnical industry or medical research environment strongly desired.
    • Extensive experience interpreting federal regulations, applying sponsor guidelines, policies and practices and complex sponsor requirements and recommending actions and resolving complex issues.
    • Possesses thorough knowledge of the Good Clinical Practice (GCP) guidelines and the applicable FDA and ICH regulations for conducting clinical
    • Familiarity with basic contract law and standard legal forms and analytical reasoning desired.
    • Self-starter with excellent verbal, written, presentation, and interpersonal communication skills and ability to work with internal and external sources to understand what action is needed to obtain all required documentation.
    • Proven interpersonal skills with the ability to work collaboratively as a member of cross-functional teams, and ability to establish and maintain effective working relationships.
    • Proficiency with designing tools and working with electronic systems used to manage clinical trial data or safety reporting.
    • Must have mature and professional communications skills, strong independent time management skills and the ability to multi-task.
    • Demonstrated ability to maintain confidentiality.

    Preferred

    • Master’s Degree in health care related field
    • Working knowledge of regulatory guidelines and expertise in quality for the advancement of therapeutics through different phases of development.
    • Clinical research and compliance, PM certification

    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.

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