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  • ID
    #7260793
  • Job type
    Contract
  • Salary
    USD $70 - $71 per hour 70 - 71 per hour
  • Source
    Volt Services Group
  • Date
    2020-12-23
  • Deadline
    2021-02-21
 
Contract

Vacancy expired!

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.

Vacancy expired!

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