Clinical Research Associate II (Medtech)

TL;DR

Clinical Research Associate II (Medtech): Delivering quality monitoring reports and ensuring data integrity and patient safety in clinical trials for biotech, medtech, and specialty pharma companies with an accent on compliance with country regulations. Focus on conducting site visits, maintaining trial master files, and understanding essential documents according to ICH/GCP guidelines.

Location: Monitoring will mainly be in Czech Republic, however, where willing, we would like if someone can cover also Slovakia.

Company

hirify.global helps biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics.

What you will do

• Deliver quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines.
• Monitor clinical trials with a focus on data integrity and patient safety in accordance with specific country regulations.
• Plan day-to-day activities for monitoring of a clinical study and set priorities per site.
• Prepare for and conduct on-site qualification, study initiation, interim monitoring, and close-out monitoring visits at investigator sites.
• Maintain Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines.
• Review site documents and verify they are accurate, complete, current, and include required updates.

Requirements

• Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience.
• Previous clinical research experience required, completion of CRA training program.
• Experience in monitoring complex trials or global trials or equivalent experience.
• Ideally experience of working within Neurosciences and Oncology.
• Knowledge of the local language for Slovakia is desirable.

Culture & Benefits

• Opportunity to grow and develop skills.
• Your ideas influence the way we work, and your voice matters here.
• Help deliver medical innovation that patients are desperate for.