Sr. CRA 3, Brazil, IQVIA Biotech
On-siteSão Paulo, São Paulo, Brazil
Job Summary
Independently manage and monitor clinical trial sites in Brazil to ensure compliance with study protocols, GCP, and ICH guidelines. Perform site qualification, initiation, routine monitoring, and closeout visits while partnering with investigative sites to support patient recruitment and retention. Provide protocol training, resolve data queries, review source documentation, and maintain regulatory records through timely reporting. Track study milestones and oversee site performance as a key member of the study team. Collaborate with cross-functional teams and mentor junior CRAs through co-monitoring activities.
Required Qualifications
- Bachelor's degree in a scientific, healthcare, or related discipline (or equivalent combination of education and experience)
- Minimum of 4 years of on-site clinical monitoring experience
- Strong knowledge of GCP, ICH guidelines, FDA regulations, and clinical trial processes
- Experience conducting monitoring visits across multiple phases of clinical research
- Excellent organizational, communication, and problem-solving skills
- Ability to effectively manage multiple priorities in a fast-paced environment
- Proficiency with Microsoft Office applications and clinical trial systems
- Valid driver's license (implied by 'on-site' requirement and travel context)
- Zero tolerance for candidate fraud (integrity requirement)
Desired Qualifications
- Strong therapeutic area knowledge and protocol management experience
- Proven ability to build productive relationships with investigative sites, sponsors, and internal study teams
- Experience mentoring or supporting the development of junior clinical research professionals
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