• Clinical Trials Manager

    Job ID
    11945
    Type
    Regular Full-Time
    Company
    Fred Hutchinson Cancer Research Center
    Location
    US-WA-Seattle
    Category
    Allied Health
  • 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 Cancer Immunotherapy Trials Network (CITN) is a National Cancer Institute (NCI) sponsored network initiated to stimulate the conduct of early (Phase I and Phase II) clinical trials in the area of cancer immunotherapy.

    The network is coordinated through a Central Operations and Statistical Center (COSC), which is housed at Fred Hutchinson Cancer Research Center. The Network is supported by an NCI contract, and a commitment of substantial NCI services, augmented by Fred Hutchinson Cancer Research Center (FHCRC) institutional funds.

    We are seeking an energetic individual with substantial background in clinical research for the position of Clinical Trial Manager (CTM). The CTM will report directly to the CITN Administrative Director. The CTM will be responsible for working closely with CITN COSC staff to implement and manage CITN protocols being conducted at Network clinical sites in addition to helping with a variety of protocol development tasks.

    Responsibilities

    The CTM serves as the primary contact for Network sites and others involved in protocol operations and study conduct. This position will be responsible for the operational management and the oversight of clinical trials within the COSC.

    Special skills, knowledge and judgment are applied in independently managing site-level project/study operations, in developing methods and materials, in conducting protocol training, and in carrying-out complex, multi-site research management responsibilities. Problems and challenges that arise in the implementation of projects/studies are handled by the CTM, soliciting assistance from other stakeholders and informing the COSC team as appropriate.

    • Manage all operational components of several protocols, working with other stakeholder groups as appropriate
    • Actively assist in writing and developing protocols and informed consent documents with an emphasis on operations. Represent the protocol team in developing, reviewing and/or revising research materials including SOPs, questionnaires, data collection instruments (e-crfs), educational materials, and recruitment materials in collaboration with other members of the protocol team
    • Develop, interpret, and administer project/study policies and procedures according to protocol, IRB, grant/contract, data management center, laboratory program and Fred Hutchinson Cancer Research Center
    • Ensure efficient protocol start-up & implementation at study sites by facilitating or liaising between sites, other functional units within the CITN, the developer, the sponsor and others as needed. Manage expectations for COSC, CITN Leadership and sites related to study implementation, including the start-up timeline, enrollment, and site performance
    • Serve as project/study liaison, representing the project/study to other functional units within the CITN. Serve as the first point of contact when problems pertaining to a particular protocol and/or site arise. Ensure rapid resolution of study issues/problems as they arise using appropriate internal and/or external resources. Develop plans for addressing deficiencies at study sites in collaboration with protocol team and other stakeholders
    • Represent and advocate for sites in strategic & operational discussions. Serve as the primary “go-to person” for site knowledge and site-related queries, including developing training materials to educate clinical sites on all aspects of the protocol
    • Drawing on knowledge and relationships with sites’ operations, provide input to protocol teams on site expertise and potential obstacles and challenges
    • Develop site-specific timelines and provide updates on protocol implementation such as enrollment and retention
    • Plan and attend meetings, monitor activities to ensure study and Network objectives have been met within designated time frame, and coordinate follow-up activities
    • Coordinate development of new sites as appropriate. Assess capacity of study sites to conduct research protocols in accordance with network SOPs, National Cancer Institute (NCI) requirements, and principles of Good Clinical Practice
    • Contribute to ongoing development of procedures and practices by participating in Operations Meetings and working groups as assigned

    Qualifications

    A degree in the health sciences, (i.e., RN, BSN, MPH, etc.) with experience in a clinical research setting is required. A minimum of 5 years experience in a clinical research environment, including at least 3 years experience in the management of complex programs, activities or units is needed. Experience managing clinical sites and multiple clinical projects as the Sponsor, is highly desirable.
    Excellent written and verbal communication skills, ability to manage a constantly changing list of priorities while staying organized, flexibility and a sense of humor are essential. Strong desire to perform a variety of tasks is necessary.

     

    Knowledge, Skills, and Abilities

    • Excellent written and oral communication skills
    • Strong skills in facilitating and building consensus in an interdisciplinary team environment
    • Able to multi-task efficiently
    • Ability to build successful working relationships with relevant network partners
    • Actively seeks out new opportunities and responsibilities
    • Self-motivated and able to work independently with minimal supervision using strong organizational, project and time management skills
    • Strong problem solving skills
    • Strong collaborative and leadership skills
    • Excellent organizational skills with keen attention to detail
    • Ability to prioritize competing demands to successfully meet deadlines and project milestones.
    • Extensive knowledge of regulatory aspects of clinical research, e.g., IRB, HIPAA, and FDA requirements for the conduct of research.
    • Clinical trial monitoring or auditing experience a plus
    • Understanding of Sponsor role and responsibilities required

    Pay, Benefits, & Work Schedule
    Salary competitive with industry and level of experience, excellent benefits, ability to have a flexible work schedule, both in the number of hours and days is required.

    Travel to national meetings is required. It is expected that some days will be longer than 8 hours.

    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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