Karyopharm Therapeutics Inc.

  • Senior Clinical Trial Associate (Sr CTA)

    Job Locations US-MA-Newton
    Job ID
    2019-1340
    # of Openings
    1
    Category
    Clinical Operations
    Type
    Regular Full-Time
  • Responsibilities

    Responsible for assisting and providing support to the members of the clinical operations project team (e.g., Clinical Project/Trial Managers, Head of Clinical Operations), to facilitate the management of the clinical trial processes including planning and execution of in- house or outsourced clinical trials. The Sr. Clinical Trial Associate (CTA) assists in supporting the conduct of trials and will be responsible for managing specific study and operational tasks. The Sr. CTA performs work within established protocols under general supervision and may act as mentor to inexperienced CTAs / new starters in clinical research.

    • Manage study specific PO Creation.
    • Responsible to ensure Clintrials.gov is updated accordingly.
    • Participate in creation and distribution of specific study aides/materials and communications.
    • Provides input and coordinates the delivery of clinical trial supplies in collaboration with the clinical supply team.
    • Facilitate CDAs.
    • Collect & collate documents required for EC/IRB/HA submissions.
    • Assist Clinical Project/Trial Manager in tracking study related activities.
    • Review background information of potential new sites.
    • Agenda distribution & minute taking for internal study team meetings.
    • Support SUSAR distribution.
    • 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 contact lists.
    • Maintain knowledge and act as team super user for related systems (e.g. TransPerfect eTMF).
    • Responsible for the development of any mass site communication as appropriate.
    • Maintain up to date training records per Karyopharm SOPs, processes and procedures.
    • Participate in inter-departmental workgroups to create or enhance processes.
    • Take on career developmental activities/tasks as necessary.
    • Under supervision of Clinical Project/Trial Manager or Clinical Head, 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.
    • Track and report on progress of the study including site activation, patient enrollment and monitoring visits.
    • Assists the CTM in identification of potential risks to the enrollment targets based on feasibility analysis.
    • Working with external vendors under supervision.
    • Work with CRAs in proactively maintaining / up-dating essential documents as required, to ensure compliance with protocol and regulations.
    • Contact sites as needed for data entry/data quality concerns and alert CRA of any issues prior to the next scheduled monitoring visit.
    • Assist with study start-up activities including development of the first draft of the ICF.
    • Up to 10% domestic and/or international travel may be required.

    Qualifications

    • Bachelor's degree or nursing degree is required. Scientific/health care field preferred, but not required.
    • Minimum of 2 years’ experience in relevant field (e.g. clinical site, CRO, Sponsor or clinical trial vendor).
    • Relevant experience in clinical research or related field.
    • Adequate Good Clinical Practice training.
    • General knowledge of guidelines governing clinical research.
    • Comfortable with technology and ability to learn new systems quickly.
    • 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.
    • 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.

    Overview

    Karyopharm Therapeutics is a clinical-stage pharmaceutical company, based in Newton, MA, USA, focused on the discovery, development and commercialization of novel, first-in-class agents targeting nuclear transport for the treatment of cancer and other major diseases. Karyopharm is the industry leader in oral Selective Inhibitor of Nuclear Export (SINE) technology, developed to address a central mechanism of oncogenesis via the inhibition of exportins specifically XPO1. Selinexor, Karyopharm’s lead candidate, has been administered to patients with hematologic malignancies or solid tumors in clinical trials worldwide. Karyopharm is currently preparing for its first potential U.S. commercial launch in 2019.

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