Senior Clinical Research Associate, Brazil

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Oversee the management of study sites to ensure patient safety and maintain high-quality data.

• Provide guidance at both site and project levels for audit readiness and assist with follow-up actions after audits.

• Maintain tools, systems, and status reports specific to trial management.

• Manage the site start-up process, which includes investigator feasibility and recruitment, EC/IRB submissions, regulatory documentation, informed consents, notifications, translations, and meetings.

• Assist in negotiating study budgets and investigator contracts when necessary.

• Verify the informed-consent processes and evaluate patient safety, data integrity, protocol deviations, and pharmacovigilance matters.

• Conduct pre-study, qualification, initiation, routine monitoring, and close-out visits, including oversight of monitoring visits.

• Prepare timely monitoring reports and necessary study documentation.

• Support strategies for patient recruitment, retention, and awareness.

• Review and reconcile Investigator Site Files with Trial Master Files.

• Communicate study-related issues to site personnel as well as Precision project and clinical trial management teams.

• Manage inventory of investigational products, including reconciliation, storage, dispensing, and ensuring regulatory compliance.

• Perform reviews of EDC/CRF and patient profile data, resolve queries, and assist in data discrepancy resolution.

• Identify and process Serious Adverse Events following study protocols.

• Identify potential site risks, escalate them appropriately, and ensure their timely resolution with project oversight.

• Attend meetings with investigators, sponsors, global monitors, and participate in clinical training sessions.

• Assist in developing protocols, study documentation, CRF design, clinical trial documents, and clinical study reports.

• Mentor and train new employees and junior monitors.

• Engage with clients and contribute to proposals and client presentations.

• Initiate requests for investigator payments.

• Travel as necessary based on project requirements.

⛳️ Requirements

• Bachelor's degree or equivalent experience in a scientific or healthcare field.

• A minimum of 5 years as a CRA in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and demonstrated competencies.

• Extensive experience in site management or equivalent experience in clinical research.

• Professional-level proficiency in English, both spoken and written.

• Preferred experience in monitoring rare and complex therapeutic areas.

• Preferred experience in monitoring EDC trials and EHR records.

• Preferred experience in biopharma or a relevant therapeutic area.

• Relevant experience in country-specific site start-up is preferred.

• Preferred ability to monitor study sites in accordance with protocol monitoring guidelines, SOPs, GCP, and ICH guidelines.

• Preferred ability to travel overnight; average travel of up to 60%, with international travel as needed.

• Preferred oncology experience, particularly in early phases, for select opportunities.

• Preferred understanding of clinical trial methodology, protocols, and indications.

• Preferred ability to conduct formal presentations proficiently.

🏝️ Benefits

• Remote work opportunity in Brazil.

• Equal Opportunity Employer.

• Reasonable accommodations available for applicants with disabilities.