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Job Overview: Document Review Specialist II 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 II may responsible for reviewing revised protocols and core ICF’s. Summary of Responsibilities: 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. 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 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 Physical Demands/Work Environment: Standard office environment. Learn more about our EEO & Accommodations request here. Didn’t find what you were looking for? Join our Global Talent Network to stay connected with Fortrea, drive innovation and contribute to our mission of advancing life-saving therapies for patients worldwide. Follow us and stay updated about Fortrea on LinkedIn, Facebook, X, Instagram, YouTube and Glassdoor. At Fortrea, we're all about turning the “impossible” into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.
Fortrea
Bucharest, Romania
ICF Reviewer II.
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