Centralized Study Spec I

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.