Senior Clinical Research Associate (Medical)

TL;DR

Senior Clinical Research Associate (Medical): Managing and monitoring clinical trial sites to ensure patient safety and data quality with an accent on site management and regulatory compliance. Focus on overseeing complex study implementations, conducting site visits, and mentoring junior staff.

Location: Remote, must be based in Argentina

Company

hirify.global is a clinical research organization specializing in managing complex and advanced clinical trials.

What you will do

• Oversee all aspects of study site management to protect patient safety and ensure high data quality.
• Conduct various site visits, including pre-study, initiation, routine monitoring, and close-out visits.
• Manage site start-up procedures, including feasibility, investigator recruitment, and regulatory submissions.
• Perform IP inventory reconciliation and verify dispensing according to protocol.
• Review EDC CRF and patient profiles to resolve data discrepancies.
• Mentor and train junior monitors and new employees.

Requirements

• Location: Must be based in Argentina.
• Degree in a scientific or healthcare discipline.
• 5+ years of experience as a CRA within a CRO or pharmaceutical/biotech industry.
• English: Professional level proficiency required.
• Travel: Ability to travel overnight up to 60% of the time.
• Strong knowledge of ICH-GCP and local regulatory requirements.

Nice to have

• Graduate or postgraduate degree.
• Experience in oncology, preferably in early phases.
• Experience monitoring rare and complex therapeutic areas.
• Proficiency with EDC trials and EHR records.

Culture & Benefits

• Remote work arrangement for candidates based in Argentina.
• Opportunity to handle complex and advanced clinical assignments.
• Collaborative environment with a focus on continuous process improvement.
• Exposure to global clinical monitoring and project staff meetings.