Clinical Research Associate

Sotalent; São Paulo; Presencial; BRL 60 000 - 90 000; Tempo integral

Resumo da oferta

Sotalent is seeking a Clinical Research Associate to support the successful delivery of clinical trials. The role involves monitoring and managing clinical sites, ensuring adherence to study protocols and regulatory requirements, and maintaining the quality and integrity of trial data.

You will conduct site visits, train site personnel, track patient recruitment, and prepare monitoring reports. Collaboration with cross-functional teams and timely regulatory submissions are essential.

Qualificações

• Bachelor's degree in Life Sciences, Health Sciences or related field; or equivalent experience.
• At least 1 year of on-site clinical monitoring experience.
• Experience in oncology clinical trials is required.
• Strong knowledge of GCP, ICH guidelines and regulatory requirements.
• Strong organisational and time-management skills.
• Excellent communication and interpersonal skills.
• Ability to travel as required by the study.

Responsabilidades

• Conduct site selection, initiation, monitoring and close-out visits in line with the study scope, GCP and ICH guidelines.
• Work with site teams to implement and track subject recruitment strategies against study timelines and enrollment targets.
• Deliver protocol and study-specific training to site personnel.
• Maintain regular communication with clinical sites, manage expectations and resolve issues.
• Assess site performance and compliance with study protocols, escalating quality concerns where required.
• Monitor study progress, including regulatory submissions, subject enrollment, CRF completion and data query resolution.
• Ensure essential documents are collected and maintained within the TMF and ISF.
• Prepare detailed monitoring reports, site documentation and follow-up actions.
• Collaborate with cross-functional project teams to support study delivery and project objectives.
• Support site-level recruitment planning and, where applicable, financial activities such as invoice collection and budget tracking.

Conhecimentos

GCP knowledge

Site monitoring

Regulatory compliance

Communication

Travel readiness

Formação académica

Bachelor's degree in Life Sciences or related field

Descrição da oferta de emprego

A global clinical research organisation is seeking a Clinical Research Associate to support the successful delivery of clinical trials. The role is responsible for monitoring and managing clinical sites, ensuring compliance with study protocols and regulatory requirements, and maintaining the quality and integrity of clinical research data.

Key Responsibilities

• Conduct site selection, initiation, monitoring and close-out visits in line with the study scope, GCP and ICH guidelines.
• Work with site teams to implement and track subject recruitment strategies against study timelines and enrollment targets.
• Deliver protocol and study-specific training to site personnel.
• Maintain regular communication with clinical sites, manage expectations and resolve issues.
• Assess site performance and compliance with study protocols, escalating quality concerns where required.
• Monitor study progress, including regulatory submissions, subject enrollment, CRF completion and resolution of data queries.
• Ensure essential documents are collected and maintained within the Trial Master File (TMF) and Investigator Site File (ISF).
• Prepare detailed monitoring reports, site documentation and follow-up actions.
• Collaborate with cross-functional project teams to support study delivery and project objectives.
• Support site-level recruitment planning and, where applicable, financial activities such as invoice collection and budget tracking.

Requirements

• Bachelor's degree in Life Sciences, Health Sciences or a related field, or equivalent experience.
• At least 1 year of on-site clinical monitoring experience.
• Experience in oncology clinical trials is required.
• Strong knowledge of Good Clinical Practice (GCP), ICH guidelines and applicable regulatory requirements.
• Strong organisational and time-management skills.
• Excellent communication and interpersonal skills.
• Ability to work effectively with clinical sites and cross-functional teams.
• Willingness and ability to travel as required by the study.