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Profile Id: 138540    3-Jan-2019
 
 
Title:   Clinical Research Professional
Name:   HIRAL SONI (M. Phil, M.Sc in Life Science)
Location:   Ahmedabad - Gujarat -
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Doctors / Specialists / Medical  
  • Laboratory
  • Microbiologist
 
 

Dear Patron ,

I prefer type of work - Part-Time, Full-Time, Contract Basis. .

My Skill - Specialised in clinical trial monitoring and Quality audits.

My prefered location for assignment - Anywhere

Jobs handled -

 Knowledge of ICH/GCP, ICMR, schedule Y, GLP, GMP, ISO 9001:2008 (Quality Management System), ISO 17025:2005 (Quality Management System and Internal Audit), ISO 15189:2012 and NABL 112 (Laboratory Quality Management and Internal Audit).

 Monitoring of clinical phases, clinical close out, bioanalytical In-process, bioanalytical close out, site initiation, site interim monitoring visit and site close out for pharmacokinetic and bioequivalence studies.

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 Responsible for registration of clinical trials on Clinical Trial Registry of India website.

 Managed regulatory authority applications for investigational new drug and medical device for different countries, prepare regulatory dossier as per schedule Y and regulatory guidelines, submission of regulatory dossier to DCGI to gain trial approval and prepared responses for regulatory queries raised by DCGI.

 Reviewed Institutional Ethics Committee (IEC) dossier.

 Structured and registered Institutional Ethics Committee for clients as per ICMR guideline and Schedule Y.

 Prepared training agenda and give training.

 Performed quality check of clinical data by verifying data of paper CRF and software system.

 Communicated with sponsor, site or CRO for project status, scheduling of monitoring visits or any other project related queries for pharmacokinetics and bioequivalence studies.

 Prepared pharmacovigilance system for clients.

 Monitored clinical phases, clinical close out, bioanalytical In-process, bioanalytical close out, site initiation, site interim monitoring visit and site close out for pharmacokinetic and bioequivalence studies as sponsorís representative.

 Prepared and reviewed monitoring reports. Prepare compliance verification responses of study audit and closure of the audit reports.


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