Karyopharm Therapeutics Inc.

  • Clinical Research Monitor

    Job Locations US-MA-Newton
    Job ID
    2019-1348
    # of Openings
    1
    Category
    Research and Development
    Type
    Regular Full-Time
  • Responsibilities

    The individual in this position will play a key role in educating clinical trial sites and clinical research associates on Karyopharm products, protocol requirements, and supportive care guidelines. Effective internal and external customer interactions will be the focal point of this position. This person will provide protocol education and support  to internal stakeholders and external collaborators  participating in Karyopharm-sponsored clinical trials.  The Clinical Research Monitor (CRM) role is a position that is comprised of licensed registered nurses or licensed advanced practice providers (Nurse Practitioner, Physician Assistant). The CRM is responsible for monitoring patient data under the supervision of the medical monitor and focuses on outreach and educating clinical site contacts (research nurses, study coordinators, investigators) on Karyopharm products and protocols.   The CRM serves as a resource to clinical sites by identifying emerging patient issues or educational needs of staff and implements training or outreach to fulfill knowledge gaps.

    The CRM  may also establish ongoing relationships with local and regional advocacy organizations and societies as assigned. This collaborative approach will serve to provide education and enhanced clinical care, and to build strategic relationships with key nurse opinion leaders.  

    RESPONSIBILITIES:

     

    • Support recruitment activities by reviewing screening data and confirming patient eligibility for Karyopharm-sponsored clinical trials
    • Monitors patient data and communicate with site study teams to obtain updates on patient status or site education needs
    • Provides site training and guidance on Karyopharm products and Karyopharm-sponsored clinical trials
    • Resolves routine study questions from clinical trial sites in adherence to ICH GCP and the study protocol
    • Oversees ongoing protocol operations to ensure study compliance and troubleshoots possible protocol violations
    • Coordinates various activities to ensure proper and timely filing of serious adverse events, protocol deviations, amendments, annual reports, and other regulatory documents
    • Prepares and/or reviews study-related materials and resources (e.g., Site Initiation training, , Case Report Forms )
    • Maintains oversight of protocol implementation by reviewing progress reports from CROs, monitoring reports, and audit reports as needed
    • Collaborates on study-specific materials for research participant education
    • Manages site relationships to ensure positive interactions through routine site contact
    • May visit off-site collaborative centers
    • Work cross functionally to identify customer education needs
    • Deliver disease state and protocol-specific educational presentations to nurses, physicians and other health care providers
    • Partner with national, state and local nursing organizations to support education on assigned disease states.
    • Develop relationships with key nurse opinion leaders.
    • Attend and participate in internal/external meetings, training classes conventions/conferences, and other business-related activities
    • Excellent organizational, creative and analytical problem solving, and influential skills are required. This individual must be flexible and adaptable to new and constant changing situations.

    Qualifications

    • Minimum of two years of recent oncology experience that includes, but is not limited to direct patient care, physical assessment, symptom management, patient education
    • 2+ years’ experience as clinical research nurse or advance practice provider in an oncology setting strongly preferred
    • Valid motor vehicle license.
    • Registered nursing/advance practice license to be in good standing in at least one state.
    • Proven success utilizing good communication, speaking, and writing skills when interacting with customers.
    • Effective communication skills, including formal slide presentations.
    • Demonstrated analytic and problem-solving skills in the healthcare environment

    Overview

    Karyopharm Therapeutics is a global commercial-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.

     

    Karyopharm Therapeutics Inc. (the "Company") is an equal opportunity employer.  All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law.  Consistent with its obligations under applicable law, the Company will make reasonable accommodations for qualified individuals with disabilities.  If you require an accommodation in the application process, please contact a member of the Company’s Human Resources department.

     

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