Clinical research associate pl – São Paulo/SP

Responsibilities include, but are not limited to

• Develop and maintain strong relationships with study sites to ensure continuity and success throughout the trial phases.
• Perform clinical study site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, local laws, and regulations.
• Gain an in-depth understanding of study protocols and related procedures.
• Coordinate and manage various tasks in collaboration with other sponsor roles to achieve “Site Ready” status.
• Participate in site selection and validation activities, providing valuable input.
• Conduct remote and on-site monitoring and oversight activities to ensure data integrity and the protection of subjects’ rights, safety, and well-being.
• Conduct comprehensive site visits, including initiation, monitoring, and close-out visits, and document findings accurately and timely.
• Collect, review, and manage required regulatory documentation for study start-up, maintenance, and close-out phases.
• Communicate effectively with investigators and site staff regarding protocol conduct, recruitment, retention, protocol deviations, and overall site performance.
• Identify, assess, and resolve site performance, quality, or compliance issues in collaboration with stakeholders.
• Work in partnership with internal and external teams to support assigned sites.
• Manage and maintain information in Clinical Trial Management Systems (CTMS), electronic Trial Master Files (eTMF), and other relevant systems.
• Act as a Subject Matter Expert (SME) within the CRA team, mentoring colleagues and sharing best practices.
• Support and/or lead audit and inspection activities as required.
• Perform co-monitoring visits when appropriate.
• Contribute to the identification of new potential sites and assist in developing their clinical research capabilities.

Requirements

• Education: Bachelors degree required, with emphasis in life sciences, biology, or related fields.
• Experience: Previous experience in the role of Clinical Research Associate is essential.
• Languages: Fluent in Portuguese and possess advanced English (verbal and written).
• Understanding of clinical research processes, phases of clinical trials, and current ICH Good Clinical Practice & country-specific clinical research laws and guidelines.
• Hands-on knowledge of Good Documentation Practices.
• Developing skills in site management, including performance management and patient recruitment.
• Strong monitoring skills complemented by independent professional judgment.
• Ability to perform root cause analysis and implement preventive and corrective actions.
• Work Environment: Ability to work effectively in a matrix multicultural environment.

Marcado como: Pesquisa e Desenvolvimento, Saúde