ICF Reviewer II

Document Review Specialist I is responsible for reviewing Informed Consent Forms and Advertisements following project and country specific regulations as well as ICH-GCP, FDA and other regional guidance. Document Review Specialist I may responsible for reviewing revised protocols and core ICF’s.

• →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 protocol amendment to reconfirm completeness and to assure compliance with Good Clinical Practice (GCP) guidelines.
• →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.
• →And all other duties as needed or assigned.

• 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

• 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

• 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.

• Standard office environment.

Learn more about our EEO & Accommodations request here.