Fortrea
ICF Reviewer I
Bulgaria · Work style not stated · Full time
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About the role
Description from the employer’s posting. Check the employer’s page for the current version.
- EmployerFortrea
- LocationBulgaria
- Work styleWork style not stated
- Employment typeFull time
- Employer posted
Summary of Responsibilities:
Review and implementation of relevant study-specific plans that describe the required expectations for assigned tasks
Support system compliance and system data entry, as applicable
File required task-related documentation in the Electronic Trial Master File (eTMF)
Review initial/amended Country/Site ICFs in compliance with Sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines.
Liaising and follow-up with local teams, Start-up Project Managers, and Sponsors to assure timely approval of Informed Consent Forms in order to meet submission deadlines.
Qualifications (Minimum Required):
• 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)
Show full description
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements
Experience (Minimum Required):
• 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.
Preferred Qualifications Include:
• 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
Learn more about our EEO & Accommodations request here.
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At a glance
- Employment typeFull time
- Employer posted
- Added to ROLIVA
- Last checked
Skills in this posting
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