Centralized Study Spec I

ArgentinaRemote

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

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