Clinical Research Associate

HungaroTrial is the largest regional CRO in Central and Eastern Europe with 10 offices in the region and USA, plus Business Development office in London, UK. Due to the expansion of our operations in the USA we are looking for CRA colleagues with at least 2 years of active monitoring experience.

As a Clinical Research Associate you will be responsible for a variety of monitoring tasks and you will have a chance to work on clinical studies in different therapeutic indications, ensuring the clinical trial is conducted in compliance with study protocol and procedures, ICH-GCP guidelines and the applicable regulations and SOPs.

Main duties and responsibilities

• Initiate, monitor and close-out clinical studies on study sites in accordance with applicable regulations, guidelines of ICH-GCP and standard operation procedures;
• Prepare and perform regulatory and ethics submission (drug, medical device, non-interventional) for approval in accordance with applicable regulations, guidelines of ICH GCP and standard operation procedures of HungaroTrial (e.g. able to perform initial CA and EC submissions, amendment, notification, progress and safety report submissions, contract negotiations without direct supervision);
• Supportcontracting procedure between Sponsor and Investigational sites;
• Perform feasibilities and pre-study evaluations ;
• Document activity in accordance with ICH-GCP and standard operation procedures of HungaroTrial;
• Prepare a summary (report) of activities as requested by the Manager.

Requirements

What we can offer

We take special attention to the balance of the work and your private life.