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    Clinical Trials Specialist - United Kingdom - Neurocrine Biosciences

    Neurocrine Biosciences
    Neurocrine Biosciences United Kingdom

    1 week ago

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    Description
    Specialist, Clinical Trials page is loaded Specialist, Clinical Trials
    Apply remote type On-Site locations United Kingdom time type Full time posted on Posted 2 Days Ago job requisition id R4357

    Who We Are:

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options.

    Supports the operational activities for planning, initiation, conduct and close out of assigned Clinical Studies (domestic and global studies). Key contributor to clinical studies using Contract Research Organizations (CROs) and internally run studies.

    Manages essential document collection and Institutional Review Board (IRB) and Ethics Committee (IEC) submission and approval procedures from start up through closeout for assigned trials.

    Collaborates with clinical research colleagues within Neurocrine, at Contract Research Organizations (CROs), and at Investigator sites to conduct clinical trials adhering to Good Clinical Practice (GCP) and ensuring accurate data, subject safety and impeccable documentation.

    _
    Working with the Clinical Trial Managers (CTMs), helps ensure clinical studies are conducted in compliance with Food and Drug Administration (FDA) regulations, EU Directive, International Conference on Harmonization (ICH) guidelines, and NBI Standard Operating Procedures (SOPs) and policies
    Serves as a team member for of assigned clinical studies
    Prepares data / information for technical and study design discussions
    Provides administrative support, ensuring invoices are paid, tracking metrics, issues for CROs and other contract service providers (CSPs) for assigned studies
    Helps with recruitment efforts
    Participates in internally run studies including updating monitoring plans, documenting on-site monitoring guidelines, forms, tools and may participate in onsite monitoring and co-monitoring visits, as necessary
    Collaborates with CTM and fellow team members to expedite study start up processes for trials and to resolve quality issues with documents
    Coordinates site essential document collection for assigned studies and maintain complete and accurate essential documents for the duration of the study
    Develops Consent Documents (CDs), and reviews site CDs following regulatory requirements and NBI SOPs

    Ensures eTMF documents are maintained in an organized manner in accordance with CRO and/or NBI SOPs, policies and standards.

    Performs sponsor oversight eTMF QC or Inspection Readiness QC within the eTMF system. Works with the NBI and/or the CRO study team to resolve eTMF QC findings and ensure the eTMF QC is documented
    Ensures eTMF QC is performed according to the schedule outlined in the TMF Plan, if available
    BS/BA in Scientific field or equivalent and 2+ years of clinical trials or operations OR
    Master's degree in Scientific field or equivalent
    Strong computer skills
    Ability to meet multiple deadlines across a project/program, with a high degree of accuracy and efficiency
    Developing project management skills
    Ability at analyzing data and information to derive options/recommendations for management considerations
    Working knowledge of clinical operations, specifically conducting clinical studies from start-up through close-out
    General understanding of Clinical Research industry and the relevant environments in which it operates
    Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

    We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements.

    We do the right thing for patients and our community.
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