Clinical Research Associate - Experienced II/Sr

Accountabilities:: Clinical Site Monitoring: Conduct on-site and remote monitoring visits to clinical trial sites, ensuring compliance with study protocols, applicable regulations, and established quality standards. Monitor site activities throughout the clinical trial lifecycle, identifying potential issues and ensuring appropriate follow-up. Site Relationship Management: Build and maintain strong professional relationships with principal investigators, clinical research coordinators, and other site personnel. Provide ongoing guidance and support to clinical trial sites to facilitate effective study execution and adherence to protocols. Study Documentation and Reporting: Manage and review site-level clinical trial documentation, ensuring accuracy, completeness, and compliance with applicable requirements. Maintain accurate and timely updates across clinical trial management systems and other relevant study platforms. Prepare and submit monitoring visit reports, documenting findings, outstanding issues, and required follow-up actions. Quality Assurance and Compliance: Identify deviations, operational challenges, and potential compliance risks, implementing or coordinating corrective and preventive actions when necessary. Ensure clinical trial sites remain audit- and inspection-ready throughout the study. Support the maintenance of study integrity, data quality, and participant safety by monitoring adherence to clinical protocols and regulatory standards. Cross-Functional Collaboration: Work closely with project managers, clinical operations teams, and other stakeholders to support study objectives and meet project timelines. Communicate monitoring findings, site progress, risks, and operational concerns effectively to relevant project stakeholders. Adapt to changing study priorities and collaborate with both virtual and on-site teams to ensure consistent clinical trial delivery. Requirements: Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related scientific or healthcare field. At least 1 year of professional experience as a Clinical Research Associate (CRA), with practical exposure to clinical trial monitoring activities. Previous experience conducting on-site and remote monitoring visits and supporting clinical trial site operations. Strong understanding of clinical research processes, study protocols, regulatory requirements, and clinical trial quality standards. Ability to review clinical trial documentation, identify discrepancies, prepare monitoring reports, and follow up on outstanding issues. Knowledge of corrective and preventive action processes and clinical site compliance requirements. Excellent organizational skills and attention to detail, with the ability to manage multiple priorities and meet project deadlines. Strong analytical and problem-solving abilities, with the confidence to identify risks and independently determine appropriate next steps. Excellent written and verbal communication skills, with the ability to establish effective working relationships with investigators, site personnel, and cross-functional teams. Fluency in both English and Portuguese is required. Ability to work independently while remaining collaborative, adaptable, accountable, and responsive in a fast-paced environment. Willingness and availability to travel regularly for clinical site monitoring visits. Valid driver's license. Must currently reside in one of the following Brazilian cities: São Paulo, Rio de Janeiro, Curitiba, or Porto Alegre. Comfortable working with both virtual and in-person teams in an international clinical research environment. Benefits: Fully Remote Work: Home-based position for eligible candidates residing in São Paulo, Rio de Janeiro, Curitiba, or Porto Alegre. Flexible Working Arrangements: Work-life balance and flexibility to help accommodate professional and personal commitments. Meaningful Impact: Opportunity to contribute to innovative clinical research projects and the development of treatments that improve patient health. Professional Development: Access to continuous learning opportunities and career advancement within the clinical research field. International Exposure: Collaborate with diverse, cross-functional teams and gain experience across different clinical research projects. Collaborative Environment: Join a supportive and inclusive workplace that values professional expertise, teamwork, and individual contributions. Career Growth: Opportunities to expand your clinical research knowledge, strengthen your monitoring expertise, and explore new professional pathways.