Informacje o stanowisku
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 (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;
- Prepare a summary (report) of activities as requested by the Manager.
Requirements:
- Bachelor degree in life sciences
- at least 2 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
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
Hays Poland sp. z o.o. is an employment agency registered in a registry kept by Marshal of the Mazowieckie Voivodeship under the number 361.
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