🕒 Contract Length : Short-term (site close-out focused)
📅 Start Date : Immediate
💼 Engagement : Freelance / Independent Contractor
About the Role
We are supporting a global biotech running an oncology programme and are seeking a freelance CRA based in Mexico to support close-out activities at two clinical sites. This role is ideal for an experienced independent CRA who can step in quickly and ensure high-quality, compliant close-out execution.
Key Responsibilities
- Conduct site close-out visits in line with ICH-GCP, SOPs and study-specific requirements
- Ensure complete and accurate TMF / eTMF documentation ahead of study closure
- Reconcile investigational product, essential documents, and outstanding queries
- Verify proper reporting and resolution of AEs / SAEs before site closure
- Collaborate with sponsor and internal teams to finalise all close-out documentation
- Provide any required follow-up after the visits to ensure full inspection readiness
Requirements
Proven experience as a freelance or independent CRAExperience performing site close-out activitiesStrong understanding of GCP, ICH guidelines, and site managementAbility to work autonomously and manage tight timelinesOncology experience helpful but not essential for this assignmentFull fluency in Spanish; professional English proficiency preferred