Clinical Research Associate II (CRA) - São Paulo

About the role

IQVIA, a global provider of clinical research services, is looking for a CRA II in São Paulo. The role performs site monitoring and site management so that sites run their studies according to the protocol, applicable regulations and guidelines, and sponsor requirements.

Key responsibilities

• Carry out site monitoring visits (selection, initiation, monitoring and close-out) under the contracted scope of work and regulatory requirements such as GCP and ICH guidelines.
• Work with sites to adapt, drive and track the subject recruitment plan in line with project needs.
• Administer protocol and study training to assigned sites and keep regular contact to manage project expectations and issues.
• Evaluate the quality and integrity of site practices, escalate quality issues as appropriate, and track regulatory submissions, recruitment, CRF completion and data queries.
• Support the start-up phase and ensure site documents are available for the Trial Master File and that the Investigator's Site File is kept in line with GCP, ICH and local regulations.
• Create and maintain documentation on site management, monitoring visit findings and action plans through visit reports, follow-up letters and other study documents.
• Liaise with study team members to support project execution.

Required profile

• Bachelor's degree; a degree in a scientific discipline or health care is preferred.
• Excellent command of English, written and spoken.
• Basic knowledge of GCP and ICH guidelines and good therapeutic and protocol knowledge gained through company training.
• Attention to detail, strong communication, problem-solving and organizational skills, and ability to build working relationships with colleagues, managers and clients.

Required skills

• Proficiency in Microsoft Word, Excel and PowerPoint.
• Ability to use a laptop, and a smartphone and tablet where applicable.

What we offer

• A competitive salary and benefits package.
• Opportunities for professional growth and development of project management abilities.