Document Reviewer I
Covance
Santiago, Chile
hace 6 días

Job Overview :

  • Review Country / Site Informed Consent Form to assure compliance with sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines
  • Review Patient Recruiting materials (Advertisements) to assure compliance with sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines
  • File Informed Consent Form , Patient Recruiting materials, and Investigator Package approval documentation in TMF and eTMF
  • Review revised Core Informed Consent Forms to reconfirm compliance with sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines
  • Provide input for Corrective and Preventative Actions (CAPAs) related to Document Review activities including Informed Consent Form Review, Patient Recruiting material Review and Investigator Package Review
  • Education / Qualifications :

  • University / College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.
  • g., nursing certification, medical or laboratory technology)

  • Computer proficiency in MS Office (Word, Excel, PowerPoint, Access, Outlook e-mail and internet services)
  • Good written and oral communication skills
  • Well developed organizational skills
  • Excellent proof-reading skills
  • Good time management skills with ability to consistently prioritize workload to accommodate multiple tasks and projects
  • Ability to work independently within a flexible team environment
  • Accuracy and Attention to detail
  • Analytical and problem solving skills
  • Experience :

  • Working knowledge of ICH, FDA, IRB / IEC and other applicable regulations / guidelines
  • 2 years work experience in clinical research
  • Previous interaction with operational project teams preferred
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