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Clinical Research Associate (BA/BE)

1 - 5 years

2 - 5 Lacs

Udupi, Manipal

Posted:2 months ago| Platform: Naukri logo

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Skills Required

ICH-GCP Clinical Research GCP Bioequivalence Studies CRA Bioequivalence CRC ICF ICH

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities Performing as Sub-investigator in the assigned clinical studies Reviewing study documents Preparation of Clinical Raw data Protocol, SOP and various Regulatory compliance Protocol/ICF/CSR review Study initiation and Execution Pre study document preparation Dosing of the subjects Monitoring the study process Preparation of confinement report, clinical updates & clinical summary report Compilation of study documents as per protocol Review study documents and handing over to QA for review. Close the QA / Sponsors observation / queries Archival & Retrieval of study documents Subject safety follow-up Serving as QC in the assigned clinical studies Performing pharmacy activities. EC submission of protocols and related activities Preferred candidate profile Knowledge of ICH - GCP Knowledge in Regulatory guidelines like CDSCO, USFDA, EMEA, WHO etc., Communication skills

More Jobs at NAVITAS LIFE SCIENCES (Ecron Acunova)

Clinical Research Associate (BA/BE)

Udupi, Manipal

1 - 5 yrs
|

INR 2 - 5 Lacs

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NAVITAS LIFE SCIENCES (Ecron Acunova)
www.navitaslifesciences.com/

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1 Jobs

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