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Precision for Medicine is expanding clinical research capabilities across Latin America and seeking a Senior Clinical Research Associate to support complex clinical studies in Brazil. This is a senior individual contributor role focused on comprehensive site management and clinical trial oversight.
Key responsibilities include independently overseeing all aspects of study site management to ensure patient safety and data quality, with consistently low query levels and acceptable QA reports. The role involves providing guidance at site and project levels toward audit readiness standards and supporting audit preparation and follow-up actions.
You will establish, update, track, and maintain study-specific trial management tools, systems, and status reports. Site startup procedures are a core responsibility, including feasibility assessment, investigator recruitment, EC/IRB submission preparation, regulatory document collection and review, informed consent adaptation, and regulatory notifications. You may assist with study budget negotiation and investigator contract execution under Site Contract Management direction.
The role requires verification of informed consent processes and documentation for each subject, assessment of factors affecting subject safety and data integrity (protocol deviations, pharmacovigilance issues), and independent conduct of all site visits including pre-study qualification, initiation, routine monitoring, and closeout visits in accordance with protocol, local laws, ICH-GCP, and company SOPs. You will perform Monitoring Oversight Visits to assess other CRA team members and prepare accurate, timely monitoring reports.
Documentation responsibilities include confirmation letters, follow-up letters, trip reports, communication logs, and other project documents per SOPs and client requirements. You will support subject recruitment, retention, and awareness strategies, enter data into tracking systems, and routinely review Investigator Site Files for accuracy, timeliness, and completeness. An increased focus on training and mentoring junior staff members is expected. This role manages appropriately sized or complex clinical trials and supports Clinical Trial Managers and Project Managers as required.
