ICF Reviewer I

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.