Envision Scientific is a company involved in research, development and manufacturing of innovative products and methods for treatment of cardiovascular disease. Envision Scientific is a company pioneering in the development of Nanotechnology based applications for delivery. Envision Scientific has developed a novel polymer free nanocarrier based drug delivery system in its R&D Lab.
Post : Jr. Clinical Research Associate - 1 post
Job description
• Preparing Documents which include preparation of the documents: Protocols, Investigator's Brochure, Informed Consent Forms, Patient Information Form, Case Report Forms and other documents necessary for the conduction of the trial. Drafted Standard Operating Procedures for Clinical Trial Department.
• Preparing clinical trial presentations related to the trials for the investigators to be presented at TCT and PCR conferences for cardiology.
• Prepare Ethics Committee submission dossier and ensure timely submission of dossier for EC/IRB approval at all participating sites. Ensure communication with sites for ethics committee notifications of Serious Adverse Events, Study Progress, Protocol Deviations, and Safety Reporting etc.
• Maintain all files and documentation pertaining to studies in Trial Master File.
• To resolve all data queries or other study related queries from the site within timeframe.
• To do all regulatory as per timelines and ensure that regulatory documents are available, complete and current.
• Coordinate with investigator and department to ensure that clinical research and related activities are performed in accordance with guidelines.
• To research, write and edit clinical/statistical reports and study protocols and summarizing data for scientific publications.
Candidate Profile :
PGDCR - POST GRADUATE DIPLOMA IN CLINICAL RESEARCH , M. PHARM in Pharmacological, or any other Education Back Ground with Clinical Research.
Additional Information:
Experience : 0-1 years
Qualification : M.Pharm, D.Pharm
Location : Surat , Gujarat
Industry Type : Medical Device
Functional Area : CRA
Last date : 15th September, 2016
Send your CV at : hr@espl.net.in
Posted by
Vaibhav Desai
Envision Scintific Pvt.Ltd
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