Sr CRA I
On-siteSão Paulo, São Paulo, Brazil
Job Summary
Conduct site monitoring and management for clinical studies, including routine monitoring, closeout, initiation visits, and pre-study activities. Liaise with vendors and manage travel expenses according to Fortrea policy while ensuring audit readiness. Independently perform CRF reviews, query generation, and resolution, and track Serious Adverse Event reporting and follow-up. Serve as a lead monitor or Local Project Coordinator, assisting in protocol development, trip report reviews, and investigator meetings. Negotiate study budgets with potential investigators and assist with EC submissions and regulatory notifications. Perform Quality Control visits, recruit investigators, and mentor new employees as assigned. Requires 60-80% travel, including overnight trips, and a valid driver's license.
Required Qualifications
- University or college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
- Three (3) years of Clinical Monitoring experience
- Full understanding of Serious Adverse Event (SAE) reporting, process production on reports, narratives and follow up of SAEs
- Advanced site monitoring skills
- Advanced study site management skills
- Advanced registry administration skills
- Ability to work with minimal supervision
- Good planning and organization skills
- Good computer skills with good working knowledge of a range of computer packages
- Advanced verbal and written communication skills
- Ability to train and supervise junior staff
- Ability to resolve project-related problems and prioritizes workload for self and team
- Ability to work within a project team
- Works efficiently and effectively in a matrix environment
- Valid Driver's License
- Thorough knowledge of regulatory requirements including a basic understanding of regulatory requirements in other countries
- Thorough understanding of the drug development process
- Fluent in local office language and in English, both written and verbal
- 60-80% overnight travel
Desired Qualifications
- One (1) or more year's additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing)
- Local project coordination and/or project management experience
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