Envision Scientific Pvt. Ltd. is a leading provider of drug delivery technologies to the healthcare industry. Our developed technologies are designed to be utilized for various types of drug and different delivery systems. Its proprietary NANO ACTIVETM Technology is designed for drug delivery utilizing Nanotechnology from various types of devices and surfaces. We Vision ‘To have a Happy and Healthy World’. Envision Scientific was incorporated in 2008. The company is ISO 9001:2008 and ISO 13485:2003 certified unit. The company was listed in the top 10 companies with IP fillings in the pharmaceutical sector for the year 2010 by the government of India gazette.
Post: Jr.Clinical Research Associate - Clinical Trial
No. of Post: 01
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 time frame.
· 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
M.Pharm (pharmacology) , Diploma or PG in Clinical Research or any background related with Clinical Research work or Studies.
Additional Information:
Qualification: M.Pharm, Diploma or Degree in Clinical Research
Location: Surat, Gujarat
Job Type: Clinical Research Associate
Industry Type: Medical Device
Last Date: 5th November, 2016
Send your resume to hr@espl.net.in
Posted by,
Vaibhav Desai
Envision Scientific.Pvt.Ltd
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