Karyopharm Therapeutics Inc.

  • Clinical Trial Associate (CTA), Global Medical Research (GMR)

    Job Locations US-MA-Newton
    Job ID
    2018-1246
    # of Openings
    1
    Category
    Other
    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

    Responsible for assisting and providing support to the members of the internal and external study team members (e.g., Clinical Project/Trial Managers, Cross functional leads, Head of Global Medical Research (GMR)), to facilitate the management of the clinical trial processes including planning and execution of collaborative research studies. The Clinical Trial Associate (CTA) assists in supporting the conduct of trials and may be responsible for managing specific study and operational tasks. The CTA performs work within established protocols under general supervision.

    • Manage trial-specific POs and invoices. Obtain and upload any relevant agreements and contracts for PO creation. The CTA may also be responsible for supporting the development of budgets and tracking of invoices.
    • Maybe responsible to ensure Clintrials.gov is updated accordingly.
    • Participate in creation and distribution of specific study aides/materials and communications.
    • Facilitate CDA execution
    • Collect & collate documents required for EC/IRB/HA submissions.
    • Assist Clinical Project/Trial Manager in tracking study related activities.
    • May assist with feasibility activities of potential new sites. The CTA will track and follow up on feasibility communications. The CTA may send out site selection communication and follow up throughout the study.
    • Agenda generation and distribution & minute taking for internal departmental and study team meetings.
    • Support SUSAR distribution.
    • Support regulatory-related email distributions
    • Assists Study team with preparation for audits/inspections
    • Provides input and coordinates the delivery of clinical trial supplies in collaboration with the clinical supply team.
    • Maintain internal & external contacts lists.
    • Assist in the revision of internal regulatory documents as applicable (i.e. IB and DSUR).
    • Maintain knowledge and act as team super user for related systems (e.g. TransPerfect eTMF).
    • Update trial information within the independent research (IR) portal (i.e. drug shipment, milestone achievement, document collection, etc.) and ensure sites utilize the portal properly to input required data. Extract reports/data from the portal for internal metric presentations.
    • Responsible for the development of any mass site communication as appropriate.
    • Support CPM in communications with outside vendors and internal departments for sample collection/analysis logistics for assigned trials
    • Maintain up to date training records per Karyopharm’s SOPs, processes and procedures
    • Participate in inter-departmental workgroups to create or enhance processes.
    • Take initiative in independent tasks or projects for the GMR department.
    • Assist in program development for pipeline molecules.
    • Take on career developmental activities/tasks as necessary.
    • Under supervision of Clinical Project/Trial Manager or Head of GMR, may assist with tasks typically associated with study management such as site visits, CRA management, clinical document/ report review, ICF template generation and/or review, review IMP release packet prior to initiation, etc.
    • Up to 10% domestic and/or international travel may be required.

     

    Qualifications

    • Bachelor's degree required. Scientific/health care field preferred, but not required.
    • Minimum of 2 years of experience in relevant field (eg. Academic/clinical site, CRO, Sponsor or clinical trial vendor).
    • Pharmaceutical experience preferred.
    • Relevant experience in clinical research or related field.
    • Previous oncology experience preferred
    • Adequate Good Clinical Practice training, including knowledge of regulatory requirements and guidelines governing clinical research.
    • Strong knowledge of MS Word, Excel, PowerPoint, Outlook, and related technology which support clinical trial processes
    • 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.
    • 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.

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