About this role
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): • 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.