Associate, Clinical Research

Associate, Clinical Research

23 Dec 2021
California, Sanfernando, 91340 Sanfernando USA

Associate, Clinical Research



Description:



  • Write informed consents and edit them for sites and check for FDA requirements

  • Help negotiate the clinical trial agreement if needed with legal

  • Understand the budget and assist the budget group with negotiation if needed

  • Help prepare and write study start-up documents: slides for training sites and field clinical specialists, clinical trial project plan, Operations Manual, patient materials, writing CRFs and instructions etc.

  • Assist the site with IRB approval and renewals

  • Has performed site qualification visits

  • Site compliance deviations, data correction forms, writing corrective action plans, excellent knowledge of the regulations

  • Written adverse event narratives

  • Committee Management - assist with the DSMB activities in the collection of source for adverse events and the de-identification of source, understanding if you have the correct source per the adverse event

  • Site initiation visits and training



Requirements:



  • Bachelor degree

  • +5 of experience with European Medical Device Regulations and product recertification/remediation.



Volt is an equal opportunity employer.

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Job Details

  • ID
    JC7260793
  • State
  • City
  • Job type
    Contract
  • Salary
    USD $70 - $71 per hour 70 - 71 per hour
  • Hiring Company
    Volt Services Group
  • Date
    2020-12-23
  • Deadline
    2021-02-21
  • Category

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