ICF Reviewer II

This is a fully remote position, open to applicants in Romania, +1 more country.

📋 Description

• Evaluate the Country/Site Informed Consent Form to ensure compliance with sponsor specifications, local regulatory standards, and Good Clinical Practice (GCP) guidelines.

• Assess Patient Recruiting materials (Advertisements) to verify adherence to sponsor requirements, local regulations, and Good Clinical Practice (GCP) guidelines.

• Organize and maintain the Informed Consent Form, Patient Recruiting materials, and Investigator Package approval documentation in the TMF and eTMF.

• Examine protocol amendments to confirm completeness and compliance with Good Clinical Practice (GCP) guidelines.

• Review updated Core Informed Consent Forms to validate compliance with sponsor requirements, local regulations, and Good Clinical Practice (GCP) guidelines.

• Contribute input for Corrective and Preventative Actions (CAPAs) concerning Document Review activities, including Informed Consent Form Review, Patient Recruiting material Review, and Investigator Package Review.

• Carry out additional responsibilities as required or assigned.

⛳️ Requirements

• A University/College degree (preferably in life sciences) or certification in a related allied health field from a recognized accredited institution (e.g., nursing certification, medical or laboratory technology).

• Fortrea may accept relevant and equivalent experience as a substitute for educational qualifications.

• Familiarity with ICH, FDA, IRB/IEC, and other relevant regulations/guidelines.

• A minimum of 2 years of experience in clinical research.

• Previous experience working with operational project teams is preferred.

• Proficient in MS Office (Word, Excel, PowerPoint, Access, Outlook email, and internet services).

• Strong written and verbal communication skills.

• Well-developed organizational abilities.

• Excellent proofreading capabilities.

• Effective time management skills with the ability to prioritize tasks and manage multiple projects consistently.

• Capability to work independently while being part of a flexible team environment.

• High level of accuracy and attention to detail.

• Strong analytical and problem-solving abilities.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Retirement savings plan with company matching.

• Opportunities for professional development and career advancement.

• Flexible work hours and remote work options.