Centralized Study Spec I

Document Review Specialist I is responsible for reviewing Investigator Packages, Informed Consent Forms, and Advertisements following project and country-specific regulations, ICH-GCP, FDA, and other regional guidance. They review revised protocols and core ICFs.

Location: Argentina

Responsibilities

• Review Initial/Amended Investigator Packages to assure compliance with regulatory requirements before granting regulatory green light to a site to start enrolling patients into the clinical trial.
• 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 Investigator Package Plans that document the required quality of documents included in Investigator Packages following the available SOP with manager oversight.
• 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.

Requirements

• 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