• Clinical Research Coordinator II

    Job ID
    11386
    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.

     

    This position works with faculty and staff to facilitate investigator-initiated and pharmaceutical-sponsored clinical trials, identify research problems and design hypotheses to be tested.  The individual will be responsible for independently designing and implementing multiple research projects to test the hypotheses in human subjects and facilitate laboratory correlative work. 

     

    The Clinical Research Coordinator will have daily interaction physicians, other health care personnel (e.g. nurses, patient care coordinators, insurance companies), patients, and with pharmaceutical sponsors. The individual is also required to use independent judgment, leadership and expert knowledge of the academic clinical trial healthcare operations to effectively facilitate the work flow and promote a collaborative work environment. 

     

    The position will maintain dynamic communication with the study investigators, research staff, numerous Fred Hutch, SCCA, and UW departments, federal agencies and industry partners.  Additionally, the individual will be required to integrate information from multiple sources to ensure that all research proposals meet the requirements of FHCRC, the Food and Drug Administration, the National Institutes of Health and the study sponsor. 

    Responsibilities

    This position develops and implements procedures that ensure that all research meets or exceeds these requirements while expeditiously furthering the research objectives of the Sarcoma research team.

     

    Finally, the Clinical Research Coordinator will interact with representatives from pharmaceutical companies, health care providers and terminally ill patients in a manner that well-represents FHCRC and its associated institutions (UW and SCCA).

     

    Responsibilities will include:

    • Assist investigators and research teams with the start-up and implementation of clinical studies, including obtaining and submitting budget/billing information, implementing the IRB-approved recruitment plan, interacting with research participants, scheduling study visits, gathering data, processing specimens, presenting information to research team.
    • Develop, document and maintain study-specific procedures for protocol registration and implementation to ensure that research execution meets good clinical practice guidelines.
    • Assist in writing informed consent documents that clearly describe the nature and risks of the research project in language that is easily understandable to the individual patient.
    • Follow institutional policies and procedures that ensure compliance with all aspects of Federal Drug Administration (FDA) and National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects.
    • Design, create, revise, and complete research instruments (e.g. case report forms) as necessary to ensure quality data that correlates with research objectives.
    • Ensure that projects are executed successfully and completed within needed time frames to meet research objectives.
    • Ensure protocol compliance by managing patient appointments and coordinating with patient’s clinical providers (e.g. physicians, physician assistants, and nurses) to collect reliable and accurate data.
    • Understand clinical trial budget and billing plan for patients enrolled on clinical trials. Work with internal partners to ensure clinical trials are performed in accordance with institutional requirements for billing compliance.  Assist in financial audits as necessary. Communicate with investigators and research staff when financial milestones have been met.
    • Ensure patient safety while participating in clinical trials by monitoring patients and interacting closely with patients' clinical providers.
    • Initiate and maintain communication with outside physicians who refer patients to SCCA and/or UWMC for oncology clinical trials.
    • Prepare interim reports for the research program and sponsors to ensure that each project is moving toward timely completion.
    • Design, create, and revise research instruments as necessary to ensure quality data that correlates with research objectives; coordinate multiple protocol-specific data collection efforts for one or more research projects which may include other collaborating agencies or institutions.
    • Consult with investigators on appropriate management of participant problems and concerns; troubleshoot acute individual or departmental research issues.
    • Oversee regulatory, budgetary, contractual, and all other aspects of protocol implementation, ensuring compliance with applicable federal regulations, institutional policies, and the principles of Good Clinical Practice (GCP).
    •  May process labs for clinical trials, including collecting, centrifuging and aliquoting specimens, and ship specimens in accordance with federal and institutional biologics shipping regulations. 

    Qualifications

    • BA/BS in a life sciences field required. 
    • Experience as a research coordinator for both investigator-initiated human subjects research projects and industry-sponsored clinical trials.
    • Experience in clinical research study coordination, preferably in oncology.
    • Sound knowledge of FDA, GCP, and NIH requirements relating to research involving human subjects, including adverse event reporting and conducting projects in clinical facilities. Possesses the ability to integrate clinical providers in research processes. Experience using electronic data capture software.
    • Experience in clinical trial processes, implementation of research protocols. 
    • Excellent written and verbal communication skills. 
    • Demonstrated ability to work independently, under supervision, and be a team player. 
    • Strong computer skills and competency with Microsoft Office software.
    • Strong attention to detail and ability to multi-task, organize and prioritize multiple projects.

    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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