Clinical Research Associate

Zuventus Healthcare Ltd (Emcure Pharma)

Mumbai/Bombay

Not disclosed

Work from Office

Full Time

Min. 2 years

Job Details

Job Description

Clinical Research Associate

  1. Financial:
  • Negotiating clinical trial budget with the CROs/Investigators.

 

  1. Operational:
  • Preparation and amendment of SOPs for clinical trial activities.
  • Clinical trial sites’ qualification and selection.
  • Tracking payments made to the CRO/Investigators/Ethics Committees
  • Protocol Designing
  • Case Report Form (CRF) Designing
  • Preparation of dossier/documents for Regulatory submission
  • Addressing DCG(I) queries
  • Co-ordination with the CRO for timely completion of the clinical trial activities
  • Protocol training of the study staff
  • Monitoring and auditing clinical trial sites
  • Coordinate with investigators for conduction of clinical trials
  • Archiving study documentation and correspondence
  • Source Data Verification: Verifying that data entered in the CRFs is consistent with source data 
  • Analyzing the clinical study data
  • Preparing DCG(I) presentations
  • Preparing Clinical study reports
  • Preparing PSURs
  • Preparing manuscripts for publication
  • Reviewing the BA/BE protocols as per the regulatory requirements.

Job role

Work location

Mumbai

Department

Healthcare / Doctor / Hospital Staff

Role / Category

Pharma & Biotech Research

Employment type

Full Time

Shift

Day Shift

Job requirements

Experience

Min. 2 years

About company

Name

Zuventus Healthcare Ltd (Emcure Pharma)

Job posted by Zuventus Healthcare Ltd (Emcure Pharma)

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