Clinical Research Associate II

TL;DR

Clinical Research Associate II (Medical): Managing clinical study monitoring activities for biotech and pharma projects with an accent on data integrity, patient safety, and regulatory compliance. Focus on conducting site visits, maintaining TMF/eTMF documentation, and ensuring adherence to ICH/GCP guidelines.

Location: Must be based in Hungary

Company

A research organization supporting biotech, medtech, and specialty pharma companies in bringing new medical innovations to patients.

What you will do

• Deliver quality, timely monitoring reports for sponsor approval according to project timelines.
• Conduct on-site qualification, study initiation, interim monitoring, and close-out visits at investigator sites.
• Plan daily monitoring activities and set priorities for clinical study sites.
• Maintain and review Trial Master File (TMF/eTMF) documentation for accuracy and completeness.
• Ensure data integrity and patient safety in accordance with country-specific regulations and ICH/GCP standards.
• Manage expense submissions according to company guidelines.

Requirements

• Must be based in Hungary
• Contractor/freelance status required
• Undergraduate degree in a clinical, science, or health-related field or equivalent professional experience.
• At least 2+ years of independent clinical monitoring experience.
• Completion of a formal CRA training program.
• Understanding of ICH/GCP Section 8 essential document requirements.

Culture & Benefits

• Flexible work environment supporting work-life balance.
• Opportunity to contribute to life-changing medical innovations.
• Collaborative team culture where individual ideas are valued.
• Contract duration of 1 year at 0.5 FTE.