SZTE

University of Szeged webpage Faculty of Medicine webpage Albert Szent-Gyorgyi Health Center webpage

university of szeged

clinical research coordination office

13. dugonics tér, szeged, Hungary H-6720
+36 62/54-68-95
clin.trial@rekt.szte.hu

SITE COORDINATION

Duties of the Office include active on-site coordination, if the Principal Investigator of the study requests this service.
As part of the coordination service, our Office delegates a study coordinator for each study whose duties are the followings:
General tasks:

• knowledge of the protocol,
• completion of required trainings,
• fulfilment of tasks determined by the Principal Investigator based on the protocol within the given timeline,
• precise completion of source data in connection with coordinator’s duties.

Tasks can also include the followings as determined by Principal Investigator:

• contact with sponsor, CRO, CRA, other members of the clinical staff and patients,
• handling of Visit templates in connection with the study,
• planning, scheduling patient visits,
• handling of logs in connection with the study,
• logistics of incoming and outgoing packages, shipment,
• handling of documents,
• handling and storage of the Investigational Products and any other study materials in accordance with the instructions of Sponsor, the provisions of the Protocol, the relevant laws, and the authorities,
• follow up of validation/ calibration,
• handling and update of other site trackers, database,
• data entry into the eCRF,
• supervision of trainings, certificates and their validity,
• handling of IVRS/IWRS access requests.

The coordinators delegated by our Office are prohibited from doing medical, nursing and pharmacist activities.
In addition to the delegation of the coordinators, our Office is responsible for the training and coaching of all study coordinators at the University of Szeged.

Contact:
Sándor RÁTKAI Pharm.D. – On-site monitor
Phone: +36 62/54-55-45
E-mail: ratkai.sandor@rekt.szte.hu

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