Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance

  • Clinical Research Coordinator II

    Job ID
    13349
    Type
    Regular Full-Time
    Company
    Seattle Cancer Care Alliance
    Location
    US-WA-Seattle
  • Overview

    Seattle Cancer Care Alliance (SCCA) brings together the leading research teams and cancer specialists of Fred Hutch, Seattle Children’s, and UW Medicine. One extraordinary group whose sole mission is the pursuit of better, longer, richer lives for our patients. SCCA's purpose is to provide state-of-the-art, patient and family centered care; support the conduct of cancer clinical research and education; enhance access to improved cancer interventions; and advance the standard of cancer care regionally and beyond.

     

    The Clinical Research Coordinator is responsible for the day-to-day coordination of clinical research studies which include phases I-IV industry, investigator-initiated, and NIH sponsored research studies, and other research projects offered through Research Integration (RI). This includes screening patients for protocol eligibility, ensuring informed consent has been properly obtained, enrolling subjects, collecting data and communicating with clinic staff. This position is also 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. The Clinical Research 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.

    Responsibilities

    KEY WORKING RELATIONSHIPS

    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).

     

    KEY POSITION ACCOUNTABILITIES

     

    Regulatory/Essential Documents

    • Support the preparation, maintenance, and provisioning of continual oversight of all SCCA RI research-related regulatory documents, which includes, but may not be limited to, the following:
      • Coordinate and manage 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.
      • Create and maintain up to date regulatory documents and files. 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.
      • Assist in the development and maintenance of, and adherence to, SCCA RI’s Standard Operating Procedures (SOPs) and Work Instructions.
      • Maintain 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).
      • Coordinate and negotiate 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.
    • Prepare submissions and query responses in a timely manner to the Institutional Review Board (IRB) to assure the protection of human subjects in research. Submissions which may include investigator 1572 forms, safety reports, non-compliance/deviation reports, SAEs and 3rd Party Safety Reports and other documents that may be required by a regulatory agency or the institution.
    • Prepare for internal and external inspections, audits and monitoring visits by collaborating with the QA Specialist and clinical research coordinators to prepare regulatory binders, scheduling the monitoring visit and following up on queries related to the visit.
    • Manage clinical research regulatory information in the Clinical Trial Management System (CTMS).
    • Manage the 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.

     

    Clinical Research Coordination

    • Review and understand operational needs of protocols. Communicate protocol requirements to study teams. Work with study team to manage the day-to-day activities of the study including problem solving, communication and protocol management.
    • Collaborate with clinic providers and staff, ancillary services, and research staff regarding protocol implementation and operations.
    • Screen patients for protocol eligibility.
    • Register patients to studies.
    • Collect and enter data in a timely manner in accordance with the protocol. Resolve queries as needed.
    • Submit reports and documents as required.
    • Coordinate study drug management.
    • Participate in study start-up such as protocol implementation activities.
    • Maintain detailed records of studies and assists with maintenance of master patient logs and master study files.
    • Develop tools and materials necessary to train individuals involved in the conduct of the study.
    • Establish and organize study files.

    Qualifications

    Required

    • Minimum of 2 years of experience in a clinical research setting
    • Proficiency with email, spreadsheets, word processing, and databases
    • Experience with electronic medical records systems
    • Ability to understand and follow multiple complex protocols at multiple sites
    • Ability to organize and manage time and tasks independently
    • Ability to develop and/or present content to senior leaders and other groups
    • Problem solving skills

     

    Preferred

    • Bachelor's degree or 2 years of clinical research experience
    • Certified Clinical Research Coordinator (ACRP), Certified Clinical Research Professional (SOCRA), or equivalent certification
    • Oncology research experience
    • Knowledge of regulations and guidelines for conducting clinical research; for example, good clinical practice (ICH-GCP), Human Subjects Protections, etc.

    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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