Clinical research associate II – São Paulo/SP

Efetivo (CLT)

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.

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.