Senior Clinical Research Associate (CRA) - Brazil

About the role

IQVIA Biotech, a full-service CRO serving biotech sponsors, is looking for an experienced Senior Clinical Research Associate (Sr CRA 3) to join its Clinical Monitoring team in Brazil. You will independently manage and monitor clinical trial sites so that studies follow study protocols, Good Clinical Practice (GCP), ICH guidelines, regulatory requirements and sponsor expectations.

Key responsibilities

• Perform site monitoring activities: site qualification, initiation, routine monitoring and closeout visits
• Partner with investigative sites to support patient recruitment and retention, and provide protocol and study-related training
• Proactively identify and resolve quality or compliance issues
• Oversee site performance, track study milestones and review source documentation
• Manage data query resolution and ensure regulatory and essential documents are kept up to date
• Document monitoring activities through timely and accurate reports
• Collaborate with cross-functional teams and may mentor junior CRAs through co-monitoring and training

Required profile

• Bachelor's degree in a scientific, healthcare or related discipline (or equivalent education and experience)
• At least 4 years of on-site clinical monitoring experience
• Experience conducting monitoring visits across multiple phases of clinical research
• Excellent organizational, communication and problem-solving skills, able to manage several priorities in a fast-paced environment

Required skills

• Strong knowledge of GCP, ICH guidelines, FDA regulations and clinical trial processes
• Proficiency with Microsoft Office applications and clinical trial systems
• Preferred: strong therapeutic area knowledge, proven ability to build relationships with sites, sponsors and study teams, and experience mentoring junior clinical research professionals