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);
- Support contracting 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.
- In addition to the routine monitoring tasks, Senior CRA will be involved into the training and mentoring our junior CRA colleagues.
- All Senior CRAs will take part in the International CTL (Clinical Team Leader) training program of HungaroTrial and will have opportunity to work as junior CTL under supervision of a Senior Project Manager within 1-2 years.
- Bachelor degree in life sciences
- At least 3 years experience in CRA role
- Advanced level of English
- Confident IT skills
- Driver’s license
- Effective communication, customer focus, teamwork, time management, motivation to learn and develop
What we can offer
- Attractive and competitive salary
- Dedicated and supportive team
- Multinational environment
- Regular team buildings and company events
- Full home based work is possible