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To have the good knowledge of regulations and GCP guidelines.
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Ability to communicate properly between the physician, patient & the site head.
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Assist Senior CRC in Screening including informed consent process, randomization, enrolment& follow-up (including Telephonic Follow-up) process & procedures.
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Maintenance of Investigator Master File as per Good documentation practices & SOP including generation of source documents.
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Present in Site Initiation Visit, Monitoring Visits, Site Closeout Visit.
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CRF, e-CRF entry, Data Query resolution.
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Coordinate between the local/Central laboratory and courier for the shipment.
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Assist the pharmacist in drug accountability and temperature maintaining logs.
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Assist the Sr. CRC in maintaining the accountability of study materials and in scheduling study procedures.
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Endow the required file notes, weekly and monthly and monthly report to the reporting authority.
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Tracking the status of all study activities.
