Karyopharm Therapeutics Inc.

  • Lead Clinical Research Associate (Lead CRA) SIENDO

    Job Locations IL-Tel Aviv
    Job ID
    2018-1197
    # of Openings
    1
    Category
    Clinical Operations
    Type
    Regular Full-Time
  • Overview

    Karyopharm Therapeutics is a clinical-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.

    Responsibilities

    Oversees the progress of clinical research associates (CRAs) and clinical sites by conducting pre-study, initiation, interim and close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices. Works closely with CRAs and Clinical Project Manager to ensure high quality data is provided and compliance is maintained across all monitoring activities.
     

    • Oversees clinical monitoring activities of moderate to complex clinical trials
    • Generates and utilizes metrics tools to assure study is running per timelines and to alert CRAs to potential issues (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports)
    • Reviews monitoring visit reports and assures adherence to study timelines for report submission and finalization
    • Proactively prevents and identifies issues related to the clinical portion of the study, including study processes, monitoring or site issues
    • Communicates monitoring and site management updates or issues to team
    • Sets up and maintains Clinical Monitoring tracking tools and develops study tools and templates for monitors and site personnel
    • Provides clinical operations guidance to Clinical Trial Assistants (CTAs) and Clinical Research Associates (CRAs) as needed
    • Develops study specific CRA training materials. Trains CRA team and oversees site retraining, tracks and maintains documentation of training throughout the life of the project
    • Develops the study Clinical Monitoring Plan with the Clinical Project Manager (CPM) or designee and ensures CRA compliance
    • Presents and participates in Investigator Meetings, other study trainings and meetings as required
    • Act as mentor and co-monitor with CRAs to ensure high quality as required
    • Assist with the monitoring of difficult sites or studies
    • Assist in process development and Standard Operating Procedure (SOP) creation prepared for clinical monitoring activities

    Qualifications

    • Bachelor’s degree or nursing qualification is required. Scientific/health care field preferred, but not required
    • 3+ years of previous Clinical Research Associate (CRA) experience within a pharmaceutical company, CRO or similar organization
    • Strong knowledge of clinical research process and medical terminology.
    • Understanding of GCP/ICH guidelines
    • Knowledge of regulatory requirements and guidelines governing clinical research
    • Understanding of basic data processing functions, including electronic data capture
    • Strong knowledge of MS Word, Excel, PowerPoint and Outlook
    • Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines
    • Must be able to professionally interact and communicate with visitors, vendors and individuals at all levels of the organization
    • Ability to reason independently and recommend specific solutions in clinical settings
    • Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions
    • Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands
    • Ability to work successfully within a cross-functional team
    • Minimum of 30% domestic and/or international travel may be required

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