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 reputed company’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 reputed company to assure compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines. Review Patient reputed company materials (Advertisements) to assure compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines. File Informed Consent reputed company, Patient reputed company 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 reputed company. 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. reputed company input for Corrective and Preventative Actions (CAPAs) reputed company to Document Review activities including Informed Consent reputed company Review, Patient reputed company material Review and Investigator Package Review. And reputed company other duties as needed or assigned. Qualifications (Minimum Required): University/College degree (life science preferred), or certification in a reputed company allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) reputed company 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, reputed company, PowerPoint, reputed company, Outlook e-mail and internet services) Good written and oral communication skills Well-developed organizational skills Excellent reputed company-reading skills Good time management skills with ability to consistently prioritize workload to accommodate multiple tasks and projects Ability to work independently reputed company 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. Apply To This Job