Responsibilities:

•        In case the existence of reference research site, to send the patients which are meeting with inclusion criteria to the research site, visiting these sites and reminding voluntary participant screening procedures. 
•        During the voluntary participant recruitment period where necessary in subject pre-screening procedures; to provide assistance for purpose of review hospital folders under responsible investigator’s review and try to find suitable patients within the agreed recruitment period.  
•        Assisting to the responsible investigator for screening of the appropriate voluntary participants as defined in the protocol, (For example to schedule the appointments, to help research personnel regarding with the non-invasive process when authorised by the responsible investigator). 
•        Filing of Informed Consent Forms (ICFs) for each voluntary participants, assisting to responsible investigator as to providing the subject with a copy of ICF.   
•       To follow up the planned organizations and visits; to ensure the visit of the voluntary participant to the clinics have been performed at the appointed time 
•       During the visits, to make necessary preparations for responsible investigator with regard to implementation of the procedures in line with the related protocols (for example preparation of the to-do list, reminding investigator with these voluntary participants)
•       To send blood samples taken from voluntary participants as indicated in relevant protocol to the central/ local laboratories, arrangement and follow-up of the courier services & laboratory results, ensuring the review of laboratory results by investigator, filing of the reports pertaining to the study, informing investigator immediately to take appropriate actions in case existence of striking abnormal and signed findings. 
•      Providing assistance for to keep and file of the records of investigator’s activities precisely.
•      Providing assistance for to record the information related to voluntary participants in the source documents precisely.
•      When authorized by investigator to file hardcopies and softcopies of the data belonging to the voluntary participants to the appropriate CRF binder, e-CRF folder and subject screening cards accurately, without making any modification, if not authorized to ensure the filing of the data are completed by investigator.
•      To ensure that study specific data and documents such as electrocardiograms, laboratory values, IVRS confirmation faxes, scales completely evaluated and signed by the investigator in a timely manner and to file them appropriate binder.
•      Taking the necessary measures to maintain the sufficient quantities of the study materials, voluntary participants diaries, laboratory kits, subject identification cards and drugs to be used in the study during the clinical trial.
•      Entering the reported Adverse Event(s) (AEs) by the voluntary participants which are related and un-related to the study drug to the subject’s data folder, notifying the sponsor promptly in case occurrence of Serious Adverse Event(s) (SAEs) and to ensure related form filled by the investigator (For example epicrisis of patients, providing reported death data, hospitalization records ..).
•      Submitting all required documents to the Ministry and Ethic Committee (EC) about the notifications of the amendments on the Investigator Brochure (IB) accompanied by the study protocol during the study; protocol changes; investigator notifications; and follow-up on the decisions accordingly.
•      Filing of the correspondence letters submitted by EC and sponsor into the Investigator Binder.
•      To ensure that all the generated questionnaires related to the voluntary participant information are resolved promptly by the investigator. 
•      To provide interim analysis of the stage of the trial performed during the course of a trial, or to provide requested information related to the voluntary participants to the other evalutionary committee.
•      Informing the EC in writing, related to the completion of the clinical trial.
•      Assisting in creating an appropriate environment to keep documents relevant to clinical trials.
•      Communication channels, including phone and email, must be regularly monitored, and necessary actions should be taken daily to ensure effective communication and timely responses.