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Clinical Trial Associate

Company: Alpha Consulting Corp.
Location: Irvine
Posted on: November 8, 2018

Job Description:

CLINICAL TRIAL ASSOCIATE IRVINE, CA Project Description: Supports CTM/OSL in ensuring the assigned clinical study(ies) are run on time and to budget and are completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Client policies and procedures.

  • Regional study feasibility when necessary.
  • Tracking of site training, certification(s), delivery of ancillary supplies, etc., necessary for site activation.
  • Development of study-specific documents when necessary.
  • Regional vendor management: manage vendor issues, coordinate contract amendments, create monthly vendor accruals, process and track monthly invoices, provide quarterly budget forecast assumptions.
  • Periodic review of protocol deviations.
  • Database lock activities (interim or final lock).
  • Regional study drug management: track shipping or storage site temperature excursions and coordinate new shipment requests if necessary.
  • Regional trial master file management (TMF): ensure all documents are filed in the TMF.
  • Regional enrollment management: site activation and enrollment tracking for monthly reporting when study appropriate. Required Skills:
    • Bachlor's degree or higher.
    • Science degree: preferably in science or health-related field.
    • Previous experience of working on a clinical study.
    • 1-2 year relevant experience in pharmaceutical industry or CRO.
    • Experience supporting clinical trials preferred.
    • Handle and prioritize multiple tasks simultaneously.
    • Work effectively in a team/matrix environment.
    • Understand technical, scientific and medical information.
    • Handle conflict management and resolution.
    • Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based).
    • Knowledge of concepts of clinical research and drug development.
    • Prefer, but not a must have - Ophthalmology area experience.
    • Position is Irvine, CA based but may have option to work from home 2 days per week. This 12+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: ALPHA'S REQUIREMENT #18-01600 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE - provided by Dice (CLINICAL TRIAL ASSOCIATE OR CLINICAL TRIAL ASSISTANT OR CTA OR CLINICAL ASSOCIATE OR CLINICAL RESEARCH COORDINATOR OR CLINICAL COORDINATOR ) AND(PHARMACEUTICAL OR CRO OR PHARMACEUTICAL COMPANY ) AND

      Keywords: Alpha Consulting Corp., Irvine , Clinical Trial Associate, Healthcare , Irvine, California

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