Location: Hungary Type of Contract: Permanent, office-based / home-based Seniority: Associate
Duties associated with the role:
Site administration and site monitoring responsibility for clinical studies according to Sponsor Standard Operating Procedures, legal requirements and ICH-GCP Guidelines Performance of initiation, routine monitoring and close-out visits Active participation in start-up activities with the study team Preparation and performance of submissions to Ethics Committee Confirmation of Site/Investigator activities for payments Completing Serious Adverse Event (SAE) reporting, processing, production of reports
Desired Skills and Experience:
University degree in medicine, biotechnology, pharmacy, nursing or biology Previous experience in independent monitoring required Advanced knowledge of English Thorough knowledge of ICH-GCP guidelines including an understanding of local regulatory requirements Availability to travel Strong organizational, communication and teamwork skills Computer literacy Driving licence
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