• Clinical Research Coordinator II

    Job ID
    11537
    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 Coordinator will facilitate the planning, coordination, and implementation of investigator-initiated and industry- sponsored clinical research studies involving human subjects. The incumbent will have daily interaction with faculty, study staff, pharmaceutical sponsors, physicians, other health care personnel, and patients as a representative of the active and growing hematologic malignancy research program and will be expected to create and maintain cross-functional working relationships with internal teams and external partners.

    Under the supervision of the Clinical Trials Manager, this senior-level positon will manage a portfolio of complex interventional clinical protocols and will be required to perform his/her responsibilities with a high level of independence within the scope of study protocol(s) and institutional guidelines.

    Responsibilities

    Principal Investigator Support:

    • Serve as designee of the Principal Investigator (PI) to manage the daily clinical operations of assigned research studies in accordance with regulatory, GCP guidelines and institutional policy.
    • Review study candidates’ medical records for study eligibility and assist in screening and patient enrollment.
    • Assist with the identification and feasibility assessment of new studies.
    • Attend weekly team meetings and communicate regularly with PI on study status.

    Protocol Implementation and Study Management:

    • Develop and maintain tools for study implementation, which may include data collection tools, study reference materials, and study specific orders. Revise and utilize tools as necessary to fulfill the aims of the clinical trial.
    • Initiate scheduling of patient clinic visits, and on-going study visits. Ensure clinical procedures, lab test, and other protocol specific activities are completed as outlined in the protocols.
    • Complete requisition forms, assemble kits for upcoming research visits, transport laboratory samples, and ensure samples are processed and shipped according to study specific guidelines, while tracking and maintaining research supplies.
    • Attend all necessary internal implementation meetings and coordinate Site Initiation Visit (SIV) with sponsor.
    • Educate clinical teams, ancillary departments, and patients to ensure safe and accurate protocol implementation.
    • Ensure informed consent, initiate patient enrollment, and ensure accurate enrollment records are maintained.
    • Research, maintain, analyze, and abstract patient clinical trial data from pre-study background (e.g., previous diagnoses and treatments) through clinical trial participation and long-term follow-up.
    • Manage long-term follow-up evaluations and data collection with clinical trial participants, SCCA, and participants’ local physicians.

    Regulatory Coordination

    • Enter required study data into the institution's Clinical Trials Management System (CTMS)
    • Prepare, track, and maintain all correspondence and regulatory documentation required by Institutional Review Board (IRB), FDA, and other institutional and federal research oversight committees, including new study start-up and ongoing study activity.
    • Ensure compliance with ongoing reporting requirements including IRB and FDA initial protocol/IND submissions, annual reports, study amendment, safety reports, and unanticipated problem/noncompliance reports. Serves as primary liaison to regulatory bodies.
    • Manage the development, review, and maintenance of protocol-specific and IND-specific documents and procedures.
    • Maintain study regulatory binders. Develop and maintain study-specific procedures for third-party safety report reviews and acknowledgements.
    • Maintain IRB correspondence and regulatory documentation. Prepare consent forms, continuation review reports, protocol modifications, and other study reports.

    Other Duties Which May Be Required

    • Assist the Principal Investigator (PI) with protocol development, revision, and study analysis.
    • Collaborate with Investigational Drug Services (IDS) on drug assignment, dispensation information, and maintain regular communication regarding status of study subjects.
    • Ensure study drug self-administration and accountability with patients.
    • Perform non-clinical ECGs.
    • Administer study questionnaires.
    • Function as a protocol liaison with clinical teams, patients, and when necessary, other institutions or drug companies.
    • Maintain appropriate source documentation, and complete or assist with accurate data entry into case report forms in a timely manner.
    • Coordinate monitoring visits and respond to queries and other requests from study monitors.
    • Identify and report adverse events in accordance with protocol, regulatory guidelines, and institutional policy.
    • Understand clinical trial budget and billing plans for patients enrolled on clinical trials. Participate in the review of charges for patients on clinical trials to ensure billing compliance.
    • Travel for industry sponsored investigator meetings.
    • Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature, and maintaining professional associations.
    • Provide cross-coverage and serve as back-up coordinator for study teams in other disease groups as needed.
    • Work with internal partners to obtain and submit budget and billing information.
    • Direct supervision of data coordinator(s) and/or junior-level clinical research coordinator(s).

    Qualifications

    BA/BS required; scientific field of study helpful.   Applicant must have a minimum of 1.5 years of clinical research or related experience.  Previous experience in oncology research and/or clinical data collection is preferred.  Working knowledge of Good Clinical Practice, human subjects research, and medical terminology preferred.

     

    This position requires superior communication skills, precise attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment.  Collaborative focus is essential; flexibility, ability to work independently as well as on a team, excellent organizational skills, and proficiency in MS office are required. This position requires a flexible schedule in order to adapt to the clinic schedules of study participants. This may include some evenings. Occasional weekends may be required to attend Investigator meetings. The work may exceed 40 hours a week; for instance during times of high participant involvement or to meet data deadlines.

    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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