Senior Clinical Research Associate (Brazil)

TL;DR

Senior Clinical Research Associate (Brazil): Independently overseeing site management for complex clinical trials with an accent on patient safety, data quality, and regulatory compliance. Focus on conducting all forms of site monitoring visits, managing start-up procedures including feasibility and submissions, and mentoring junior CRAs.

Location: Remote from Brazil, up to 60% travel including international as needed

Company

hirify.global is expanding clinical research capabilities across Latin America.

What you will do

• Oversee all aspects of study site management to ensure patient safety and high data quality with low query levels.
• Conduct site visits including pre-study, initiation, routine monitoring, close-out, and monitoring oversight for other CRAs.
• Manage site start-up including feasibility, EC/IRB submissions, regulatory documents, and investigator contracts.
• Review informed consents, ISF/TMF reconciliation, IP inventory, and data in EDC/CRF.
• Identify and escalate site risks, process SAEs, and support recruitment/retention strategies.
• Mentor junior staff, attend investigator meetings, and assist in protocol/review activities.

Requirements

• English proficiency at professional level for verbal and written communication.
• 4-year college degree or equivalent in scientific/healthcare discipline.
• 5+ years as CRA in CRO/pharma/biotech with significant site management experience.
• Ability to travel up to 60% overnight based on regional requirements.
• Knowledge of ICH-GCP, local regulations, and clinical trials methodology.

Nice to have

• Graduate/postgraduate degree.
• Experience in rare/complex therapeutic areas, EDC trials, EHR, oncology (early phases).
• Site start-up experience in Brazil including feasibility and contract negotiations.
• Biopharma or relevant therapeutic area experience.

Culture & Benefits

• Remote work arrangement.
• Focus on audit readiness, continuous improvement, and professional image.
• Team collaboration with project managers, clinical trial managers, and global staff.
• Opportunities for mentoring, client interactions, and proposal activities.