Clinical Research Associate

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Research Associate based in Brazil.

This role offers the opportunity to support clinical research programs focused on advancing treatments and improving outcomes for patients.

As a primary CRA, you will oversee clinical trial sites and help ensure studies are conducted according to protocols, regulations, ICH-GCP guidelines, and applicable SOPs.

You will build strong relationships with investigators and site personnel while serving as a key communication link between sites and the broader clinical study team.

The position combines site monitoring, patient safety oversight, data quality, study training, and milestone management across the clinical trial lifecycle.

You will monitor enrollment, data entry, protocol deviations, and site performance while identifying issues and driving them toward resolution.

The role also provides opportunities to mentor less experienced CRAs and contribute to audit and inspection readiness.

Based in São Paulo in a hybrid environment, the position involves significant travel and collaboration across clinical research teams and study sites.

Accountabilities:

• Perform and coordinate assigned clinical monitoring activities in accordance with ICH-GCP requirements, applicable regulations, study protocols, and SOPs to assess the safety and efficacy of investigational products or medical devices.
• Conduct pre-study, initiation, interim monitoring, and closeout visits as required, assessing protocol and regulatory compliance and completing all necessary documentation.
• Build and maintain collaborative relationships with investigators, site personnel, study vendors, and other clinical research stakeholders.
• Provide protocol-specific and study-related training to assigned clinical sites and participate in disease indication, project, and regional training activities as required.
• Maintain oversight of site performance by monitoring enrollment, CRF data entry, protocol deviation trends, data quality, patient safety, and overall site issues.
• Communicate site performance, risks, issues, and progress to the Clinical Study Team and collaborate with stakeholders to support timely achievement of study milestones.
• Perform Serious Adverse Event reconciliation and work with clinical sites and relevant study stakeholders to resolve discrepancies.
• Support timely delivery of key clinical study milestones, including study startup, recruitment, database activities, and study closeout.
• Provide mentoring and training to less experienced CRAs, including co-monitoring and support during site visits when needed.
• Attend regional investigator meetings, site booster visits, and other study-related activities as required.
• Support clinical sites with audit and inspection preparation and ensure identified quality issues or findings are appropriately followed through to resolution.
• Take on additional clinical responsibilities within the scope of the role as required.

Requirements:

• Bachelor’s degree in a relevant scientific discipline, with at least 2 years of relevant Clinical Operations experience and at least 1 year of clinical monitoring experience.
• Experience supporting global oncology trials is preferred, as is experience within the pharmaceutical or biotechnology industry and exposure to hematology or oncology.
• Thorough understanding of clinical trial processes, ICH-GCP principles, and associated regulatory requirements.
• Experience with clinical site monitoring, compliance assessment, site management, clinical documentation, data quality, and patient safety oversight.
• Strong communication and interpersonal skills, with the ability to establish productive relationships with investigators, study teams, vendors, and other stakeholders.
• Excellent organizational and prioritization abilities, with the capacity to manage multiple activities, deadlines, and study requirements effectively.
• Fluent written and spoken English is required; Spanish language skills are a plus.
• Strong analytical thinking, attention to detail, initiative, adaptability, and a results-oriented approach.
• Ability to work collaboratively across clinical teams while independently managing assigned responsibilities.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.
• Familiarity with clinical trial management systems (CTMS) and clinical data management systems.
• Willingness and ability to travel extensively, with the role requiring up to 70% travel.

Benefits:

• Hybrid working arrangement based in São Paulo.
• Opportunity to contribute to clinical research programs focused on advancing treatments for patients.
• Exposure to global clinical trials and pharmaceutical/biotechnology research environments.
• Opportunities to develop expertise in clinical monitoring, study management, regulatory compliance, and patient safety.
• Opportunities to mentor and support less experienced clinical research professionals.
• Collaboration with multidisciplinary and international clinical study teams.
• Exposure to oncology and hematology clinical research is available depending on assigned studies.
• The source posting does not specify a salary range, healthcare coverage, paid leave, bonus structure, or additional formal benefits.
• Equal-opportunity workplace focused on qualifications, merit, collaboration, and business needs.