Ankara, Türkiye
Clinical Research Associate on assignment to AstraZeneca
Clinical Research Associate on assignment to Sanofi
Preparation\calculation for Import Licence submissions according the study protocol. Receiving, processing, shipment and delivery, return drug accountability, reconciliation and destruction of clinical supplies returned by the clinical sites of drug products and medical devices for assigned studies.
If there are reference centres to ensure referral of patients meeting study criteria to the study site, visiting referral sites and physicians at those sites and reminding them about the rules of screening subjects (volunteers). If required, reviewing hospital files under supervision of principal investigator in order to help preliminary volunteer screening procedures during the recruitment period, should all necessary permits are obtained and making efforts to find eligible volunteers, Providing help to the study team in screening volunteers who are deemed eligible to the protocol by the principal investigator (visit appointment organisation of volunteers, helping the study team in non-invasive procedures which are authorised by the principal investigator) Filing the informed consent forms obtained from volunteers, helping the principal investigator provide one copy of the form to the volunteer, Organising and monitoring appointments in order to make volunteers’ visits are performed in a timely manner, Making necessary preparations in order to help the principal investigator perform procedures in accordance with the protocol during visits (for example, making list of procedures to be performed and reminding them to the investigators), Sending blood samples drawn from volunteers to central or local laboratory as per the protocol, organisation, tracking of courier procedures, monitoring laboratory reports, making the investigator examine reports, filing reports, informing the investigator for taking immediate measure if there is a remarkable or an abnormal finding pointed in the report, Assisting the principal investigator or physician or dentist in recording all procedures in a complete manner and in filing the documents, Providing help in recording information of volunteers completely to reference documents (patient file, study file) of the hospital