About this role
Job Overview: Document Review Specialist I is responsible for reviewing Investigator Packages, 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 is responsible for reviewing revised protocols and core ICF’s.
Summary of 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.
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.