About Me
Im RISHI KUMAR.S, previously worked as a Medical Writer Clinical Research at Spinos Lifescience research pvt. Ltd., Coimbatore, Tamil Nadu, India and I have One year experience in the respected field. I assure you that I will work hard and give my best.
Job description:
Responsible of Preliminary study designing of BA/BE studies.
Preparation and Review of protocol, Investigator Brochures, sample case report form and Inform Consent Form for various regulatory like USFDA, WHO, EMA, ANVISA, Canada, China, ROW, DCGI etc,
Responsible to address the sponsor and Regulatory related queries.
Verification of protocol/SOP deviation record and clinical study/summary update which includes reporting of AEs/SAES occurred during study conduct to the sponsor/Ethics committee as required.
Site monitoring before every study initiation to ensure availability of study materials and readiness of the clinic and ICU to conduct study as per requirements. Monitoring and review of Volunteer Management.
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