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San Diego Metro Area, CA

Posted: 08/09/2018 Job Type: Clinical Job Number: JN -082018-22268
  • Completed BA/BS with at least 2 years experience as CTA experience in pharmaceutical or CRO.
  • Clinical Trials Associate (CTA) is involved in the conduct of the study and interfaces with the Study Manager and the Study Team. The CTA also supports the Study Team by creating and distributing study team materials, tools and documents.

    Responsibilities will include, but are not limited to, the following:

    1. Support the Study Team to select potential investigators and assess their interest in the study
    2. Communicate with the sites through direct contact and other tools such as newsletters as appropriate per study requirements
    3. Track study progress in CTMS including patient enrollment and patient status
    4. Oversight of Monitoring Visit Report review for CROs
    5. Support study data as the EDC administrator and by tracking CRFs and queries as appropriate for insourced studies
    6. Process and track payments to vendors and study sites as appropriate
    7. QC review of ICFs returned from the sites.

    Investigational Product reconciliation.
    Financial Reconciliation at the close of studies
    Support the Study Manager in creating, updating and tracking MS Project study plans
    Collecting, quality review and submitting documents to the TMF
    Performing quarterly QC of TMF as appropriate
    Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings with CROs and other vendors
    Generate, finalize and distribute study team agendas and meeting minutes
    Assist with generating the CSR appendices and participate in SOP and WP development
    Mentor and coach other CTAs, as appropriate, and participate or provide leadership in departmental initiatives

    Skills/Knowledge Required:

    Completed BA/BS in directly-relevant discipline or equivalent experience required
    At least 2 years experience as CTA (or comparable operating experience) in pharmaceutical or CRO required
    Computer skills - MS office suite
    CTMS (Celtrak)
    Knowledge of databases - preferred EDC (Medidata), IVRS (Endpoint)
    Efficient at meeting planning / generating minutes
    Understanding / familiarity with drug development and process and Pharma
    Strong Verbal and written communications skills
    Self starter / proactive
    Ability to work independently
    Good listener / problem solver
    Ability to prioritize and multi-task and demonstrate flexibility and attention to detail
    Familiarity with ICH / GCP and regulatory guidelines/directives
    Team player and ability to build relationships
    Strong organizational skills
    Proficient at Vendor / site payment process
    Knowledge of medical/scientific terminology
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