Clinical Researcher Jobs in Mumbai - Cyte Space ptv ltd
Job Description
Ø Execution & preparation of clinical research studies right from Site initiation, Monitoring, Close-out activities, subject recruitment & competition of the study.
Ø Conduct & monitor clinical trials for drugs in the therapeutic area of Asthma & Diabetes.
Ø Record data in Oracle, Electronic Data Capture, eCRF and resolve discrepancies.
Ø Oversee adherence to study protocol and Clinical Patient evaluation, Treatment, Administration, collection, processing and shipping of Biological Specimens.
Ø Design patient chart using spread sheet and formulate source document and data collection chart.
Ø Manage regulatory documents, clinical trials manual, maintain accurate record of adverse event, expedited report of SAE.
Ø Maintain clinical trial related document including Trial Master File (TMF), Investigator Folder, IP Accountability & IP temperature log.
Ø Reporting of SAE & communication with EC/Sponsor/CRO.
Ø Coordinate with the Ethics Committee - which safeguards the rights, safety and wellbeing of all trial subjects.
Ø Write visit reports and collate trial documentation and report.
Ø Execution & preparation of clinical research studies right from Site initiation, Monitoring, Close-out activities, subject recruitment & competition of the study.
Ø Conduct & monitor clinical trials for drugs in the therapeutic area of Asthma & Diabetes.
Ø Record data in Oracle, Electronic Data Capture, eCRF and resolve discrepancies.
Ø Oversee adherence to study protocol and Clinical Patient evaluation, Treatment, Administration, collection, processing and shipping of Biological Specimens.
Ø Design patient chart using spread sheet and formulate source document and data collection chart.
Ø Manage regulatory documents, clinical trials manual, maintain accurate record of adverse event, expedited report of SAE.
Ø Maintain clinical trial related document including Trial Master File (TMF), Investigator Folder, IP Accountability & IP temperature log.
Ø Reporting of SAE & communication with EC/Sponsor/CRO.
Ø Coordinate with the Ethics Committee - which safeguards the rights, safety and wellbeing of all trial subjects.
Ø Write visit reports and collate trial documentation and report.
Job Particulars
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