ICF Reviewer II

Job description

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). • Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required): • Strong knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines. • 3 years’ work experience in clinical research Preferred Qualifications Include: • Computer proficiency in MS Office (Word, Excel, PowerPoint, Access, Outlook e-mail and internet services) • Excellent written and oral communication skills • Excellent organizational skills • Excellent proof-reading skills • Good time management skills with ability to consistently prioritize workload to accommodate multiple tasks and projects Learn more about our EEO & Accommodations request here .