Clinical research associate II – São Paulo/SP

SP l São Paulo
Efetivo (CLT)
Biólogo
Biomédico
Bioquímico
Farmacêutico

Responsabilidades

• Develop and maintain strong relationships with study sites throughout all phases of clinical trials.
• Ensure compliance with International Council for Harmonisation/Good Clinical Practice (ICH-GCP), local regulations, and company policies during site management and monitoring activities.
• Gain a comprehensive understanding of study protocols and related procedures.
• Coordinate tasks with other sponsor roles to achieve “Site Ready” status and participate in site selection and validation activities.
• Conduct remote and on-site monitoring to ensure data integrity and subject safety.
• Document findings accurately during site visits, including initiation, monitoring, and close-out visits.
• Collect and review regulatory documentation throughout study phases.
• Communicate effectively with investigators and site staff regarding protocol conduct and site performance.
• Identify and resolve site performance or compliance issues, escalating as necessary.
• Manage information in Clinical Trial Management Systems (CTMS) and electronic Trial Master Files (eTMF).
• Act as a Subject Matter Expert (SME) to share best practices and provide training.
• Support audit and inspection activities as needed.

Requisitos

• Bachelor’s degree.
• Solid experience as a Clinical Research Associate, preferably in a similar role.
• Fluent in local languages and advanced proficiency in English (verbal and written).
• Strong understanding of clinical research processes, phases of clinical trials, and ICH-GCP guidelines.
• Excellent communication skills, with the ability to present technical information effectively.
• Proven skills in site management and patient recruitment.
• Strong analytical skills to understand and act on data and metrics.
• Proficiency in MS Office and clinical IT applications.
• Ability to work independently and manage multiple tasks in a fast-paced environment.