
Oncology, Phase III breast,
Oncology, Phase II NSCLC,
Oncology, Phase III NSCLC,
Oncology, Phase III ESOPHAGUS,
As a clinical research site coordinator, mastering the protocol of Intravenous drugs that are in Phase III Stage
of Cancer drug development in Medical Oncology. In 4 different lung studies, I took part in both the blind part
and the unblind part. I carried out multi-armed and single-armed studies. I've seen too many screening and
randomization visits. I've reported multiple SAE statuses. I've had multiple monitoring visits. I observed the
preparations for the central audit.
Advanced GCP Inspection Training for Clinical Research
Oncology, Phase III SCLC, two arms, randomized, Chemotherapy+IMP
Oncology, Phase I NSCLC
Oncology, phase II/III NSCLC *
Oncology,phase III breast
Oncology,phase III esophagus
*FDA INSPECTION
• Assisting the lead investigator/co-investigator to involve the volunteer (according to eligibility criteria),
• Assisting the principal investigator and other researchers in the informed consent process,
• Recording research-related subject data in CRFs,
• AE/SAE reporting,
• Ensuring that biological samples are sent to the central laboratory,
• Ensuring that necessary documents related to researchers and field personnel are provided before the Site
Initiation Visit,
• Following the calibration of the materials used during the study and keeping the temperature records of the
medicine cabinets,
• To follow the stock of the kits belonging to the study,
• To arrange and organize the follow-up of routine visits in accordance with the protocol,
• To ensure the follow-up of the investigator file,
• Coordinating the site,
• Monitoring visits
Imedidata / Almac / Signant Health / Bioclinica / Microsoft Office / Microsoft Word / Microsoft Powerpoint / Microsoft Excel