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Posted 3 weeks agoCentralized Study Specialist - Document Reviewer
at Fortrea
Sofia, BulgariaOn-site
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 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.
- Review Initial/Amended Investigator Packages to assure compliance with regulatory
Requirements
- 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