Centralized Study Spec I
Remote · Argentina or Brazil
Job Summary
Document Review Specialist I at Fortrea is responsible for evaluating Investigator Packages, Informed Consent Forms, and advertising materials to ensure regulatory and sponsor compliance with ICH-GCP and FDA guidelines. Responsibilities include reviewing Initial/Amended Investigator Packages, country/site ICFs, and patient recruiting materials; filing documentation in TMF/eTMF; reviewing Protocol amendments; contributing to CAPAs related to document review; and supporting other related duties. Key skills include strong proofreading, organizational and time-management abilities, effective written and oral communication, independent work in a flexible team, and proficient MS Office use. This remote, globally distributed role requires life-sciences grounding and familiarity with regulatory standards to support trial setup and ongoing compliance.
Required Qualifications
- University/College degree (life science preferred) or related allied health certification
- 2 years’ work experience in clinical research
- Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines
Desired Qualifications
- Good written and oral communication skills
- Well-developed organizational skills
- Excellent proofreading skills
- Strong time management and prioritization
- Ability to work independently within a flexible team environment
- Analytical and problem-solving skills
- MS Office proficiency (Word, Excel, PowerPoint, Access, Outlook)
- Experience with TMF/eTMF documents
- Familiarity with ICH-GCP, FDA, IRB/IEC regulations
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