Clinical Research Associate - Experienced

Our clinical activities are growing rapidly, and we are currently seeking an Experienced Clinical Research Associate to join our Clinical/ Country Operations team in Prague. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

We are looking for a CRA with experience responsible for the following:

• Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol;
• Communication with the medical site staff including coordinators, clinical research physicians and their site staff;
• Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
• Medical record and research source documentation review and verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements;
• Verification that only eligible subjects are enrolled;
• Review of regulatory documents;
• Investigational product/drug and/or Medical device accountability and inventory;
• Verification and review of adverse events, serious adverse events, concomitant medications and corresponding medical condition to confirm accurate data reporting in accordance with the protocol, ICH GCP and Local Regulations;
• Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement;
• Completion of monitoring reports and follow-up letters, which includes, but is not limited to providing summaries of the site’s status, significant findings, deviations, deficiencies, and recommended actions to secure compliance.

• Minimum Bachelor’s degree, preferably in Health or Life Science related;
• Excellent command of Czech & English;
• Willing to travel approximately 60% nationally;
• Familiarity with Microsoft® Office; and
• Strong communication and presentation skills.