• Clinical Research Compliance Manager

    Job ID
    11845
    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 Clinical Research Compliance Manager is responsible for ensuring clinical research is conducted according to the highest quality standards and in compliance with local, state and federal regulations. The Compliance Manager reports to the  Assistant Director of Regulatory Affairs and Compliance in the clinical trials office, Clinical Research Support (CRS), for the Fred Hutch/University of Washington Cancer Consortium. The position collaborates with partner institutions, Office of General Counsel, Institutional Review Office, Division Administrators, Clinical Research Management and Training.

    Responsibilities

    Please include a cover letter with your application detailing your interest and qualifications for this position.

    • Prepares and implements remediation and corrective action plans, audits response timelines and escalation plans; communicates expectations in a collaborative environment
    • Conducts for-cause and spot audits of clinical trials
    • Develops, implements and maintains Compliance policies and standard operating procedures
    • Assesses resources and needs to meet NCI-Designated Cancer Center guidelines and Center strategic planning goals
    • Acts as primary Institutional contact for compliance and regulatory-related communications with outside sponsors, partners and regulatory institutions
    • Participates in Consortium study review committees
    • Coordinates with Regulatory Affairs team when needed to address regulatory-related matters
    • Defines compliance and quality metrics, performs qualitative and quantitative data analyses and reports findings to senior management
    • Assists with the development of standard training requirements and assists with ongoing compliance-related education and training for investigators and research personnel
    • Identifies compliance risks during study start-up and management; works directly with investigator and research personnel to define root causes and recommend areas of training and process improvements
    • Collaborates with partner institutions to facilitate start-up, management and audit of clinical research activities that are compliant with guidelines and regulatory requirements including billing compliance
    • Maintains visibility and awareness of the roles and resources available; represents the Program at presentations, meetings and other out-reach activities for Cancer Consortium faculty and research personnel
    • Participates in Center-wide and Cancer Consortium process improvement projects and leads quality-related improvement projects

    Qualifications

    • Bachelor’s Degree; Master’s Degree in health care related field preferred
    • Three to Five (3-5) years working experience in a research quality and/or auditing environment with expertise, knowledge, and GCP experience in auditing clinical trials, including auditing internal processes, performing sponsor audits, and proficiency with electronic systems used to manage clinical trial data or safety reporting. Oncology and/or hematology research experience preferred.
    • Assessing risk in the conduct of clinical research
    • Communicating with all levels of a research organization
    • Interpreting federal regulations and guidelines
    • Designing tools for the management of clinical research
    • Developing corrective action plans for study teams
    • Working across large academic institutions
    • Thorough understanding of the regulations governing human subjects research
    • Clinical research and compliance certification preferred

    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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