• Clinical Research Coordinator II-III

    Job ID
    12019
    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 position will work directly with an Assistant Member in the Infectious Disease Sciences Program in the Vaccine and Infectious Disease Division to provide support to the PI and research staff in the development, implementation and management of his diverse research portfolio, including research studies and clinical trials.

     

    The Clinical Research Coordinator (CRC) will be responsible for providing support on all aspects of research study and clinical trial development and implementation. Primary responsibilities of the CRC will include assistance with the planning, coordination, implementation, and close-out (e.g. presentation of data, manuscript writing) of retrospective and prospective observational or investigator-initiated interventional studies. Additional responsibilities will include communicating with internal and external collaborators and supporting study personnel in the preparation of regulatory documentation and audits if applicable.

     

    Under the supervision of the Principal Investigator, the CRC will manage a portfolio of complex research projects and will be required to perform their responsibilities with a high level of independence within the scope of study protocol(s) and institutional guidelines. The position will include interaction  with patients, physicians, researchers, and other clinical providers and support staff within and outside of the Fred Hutch/SCCA/UW system including the SCCA Patient Care Services.

    Responsibilities

    1. Principal Investigator Support:
    • Serve as designee of the PI to manage the daily research operations of assigned studies in accordance with regulatory, GCP guidelines and institutional policy. Develop, coordinate and manage research studies conducted by principal investigator including: develop study protocol, consent form, CRFs, and study procedures/SOPs; manage subject recruitment and enrollment; conduct of study intervention; and biospecimen collection and processing.

     

    1. Research Study Support:
    • Provides proactive regulatory consultation and support throughout the lifecycle of studies and clinical trials.
    • Provides representation and direct support to sponsor-investigators, clinical investigators, and staff.
    • Makes detailed observations, analyzes and interprets data, and participates in the peer-reviewed manuscript process.
    • Directs the development of templates and tools for study teams.
    • Develops internal processes and standard operating procedures for reviewing research activities.
    • Provides regulatory support as needed for clinical monitoring activities.
    • Manage monitoring visits and quality control reviews by Sponsors or Investigators.

     

    1. Protocol Implementation and Study Management:
    • Develop and maintain tools for study implementation.
    • Ensure clinical procedures, lab tests and other protocol-specific activities are completed as outlined in the protocols.
    • Educate clinical teams, ancillary departments, and patients to ensure safe and accurate protocol implementation.
    • Work with internal partners to obtain and submit budget and billing information
    • Ensure adherence to contracts and grants.
    • Serve in lead role for data coordinator(s), clinical research coordinators, and other staff on PIs projects.

     

    1. Perform clinical research support as requested.

    Qualifications

    • Clinical Research Coordinator II Minimum Education/Experience: Bachelor’s degree in scientific/medical field or equivalent experience/education. Master’s degree in healthcare related field preferred, particularly in the area of epidemiology. Minimum of three years post-master’s or five years post-bachelor’s experience in clinical study/trials coordination or related field
    • Clinical Research Coordinator III Minimum Education/Experience: Advanced Degree (Master’s level or higher) in a healthcare related field, particularly in the area of epidemiology.  Five or more years of experience in clinical study/trials coordination or related field
    • Clinical research related certification is preferred
    • Strong scientific writing skills
    • Strong organization skills
    • Strong computer skills, including proficiency in the Office Suite, and experience working with databases
    • Superior communication skills, precise attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment. Ability to work collaboratively and build relationships across multiple organizations
    • Knowledge of medical terminology and statistics required
    • Ability to perform basic statistical analyses is preferred
    • Knowledge of federal regulations and guidelines that govern clinical research, including GCP and human subjects research
    • Able to assess risk in the conduct of clinical research

    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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