Senior Clinical Research Associate (Brazil)

The role

The Senior Clinical Research Associate will handle complex assignments including start-up, study implementation, and on-site monitoring of clinical research studies. This role involves site management, supporting Clinical Trial Managers, and mentoring junior staff.

What you will do

• Oversee study site management to ensure patient safety and data quality
• Provide guidance towards audit readiness standards
• Maintain study specific trial management tools and status reports
• Manage site start up procedures including feasibility, recruitment, and regulatory submissions
• Assist in negotiating study budgets and executing investigator contracts
• Verify informed consent processes and assess patient safety factors
• Conduct site visits including pre-study, initiation, routine monitoring, and close-out
• Perform Monitoring Oversight Visits to assess other CRA team members
• Document activities via reports, logs, and tracking systems
• Perform investigational product inventory and reconciliation

Required qualifications

• 4-year college degree or equivalent experience in a scientific or healthcare discipline
• 5 years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies
• Significant site management experience or equivalent experience in clinical research
• Ability to communicate both verbally and in writing at the English proficiently (Professional level)

Nice to have

• Graduate, postgraduate degree
• Experience monitoring in rare and complex therapeutic areas
• Experience monitoring EDC trials and EHR records
• Experience in biopharma or relevant therapeutic area
• Relevant site start-up (feasibility, contract negotiations, submissions) experience for the country
• Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines
• Ability to resolves project related problems and prioritize workload to meet deadlines with oversight from management
• Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed
• Select opportunities require Oncology experience preferably in early phases
• Exhibits self-motivation and is able to work and plan independently as well as in a team environment

About the company

Precision Medicine Group is an Equal Opportunity Employer.