Job Overview:
Primary contact with investigative sites during study maintenance and -when assigned-, site startup activities, with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB/Third body/Regulatory Authority submissions are made within the timelines agreed with project management and Site Readiness team. Develop awareness of regulatory legislation, guidance, and practice in the assigned countries with the support from senior staff.

Summary of Responsibilities:
- Develop awareness of regulatory legislation, guidance, and practice in the assigned countries with the support from senior staff.
- Assist senior staff to compile, prepare, submit, and obtain approval of the submission documents to IRB/IEC/Third body/Regulatory Authority in accordance with local requirements.
- Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable).
- Perform a review of final submission documents as applicable.




- Organize communication related to the submissions/outcomes within Fortrea as applicable.
- Escalate study issues appropriately and in a timely fashion.
- Perform other duties as assigned by management depending upon country and situational requirements with proper supervision (if applicable).
- In Country specific tasks (General):
- Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.
- Collect and track all the necessary documents required and perform a quality review, formatting, and compilation of the final documents for effective and compliant site activation and maintenance.
- Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines.
- Update study documents when there are changes in study personnel/study amendments.
- Ensure high quality documents are filed and systems ar

📌 Site Readiness and Regulatory Specialist I (Buenos Aires)
🏢 Fortrea
📍 Buenos Aires