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Full-Time Opportunity: This is a permanent, full-time position with a competitive package and real career growth potential.
Job Description
Responsibilities
- Assist/advise project teams on all regulatory requirements for clinical studies
- Perform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findings
- Review and adapt study specific documents according each country and site requirements
- Perform IRB/EC (CA) and/or other Regulatory Bodies submissions on behalf of sponsors and/or sites as agreed with the Sponsor and in accordance with each country requirements
- Receive and process study documentation from sites, check content and quality as well as completeness
- Interact with site personnel, CPCs, CRAs and PMs for document corrections, clarifications, or resolution of any incomplete and/or incorrect documentation found during document content quality review
- Compile regulatory documentation according to CTI SOPs, sponsor SOPs and applicable country requirements, perform a QC revie...