Clinical Research Associate -2 - 6 Years-Mumbai

 

Job Description

• Should have minimum 2 years of core on-site monitoring experience.
• Facilitate and coordinate with investigator and site for EC submission and approval.
• Conduct site feasibility and qualification visits.
• Prepare for kick-off meetings to train vendor representatives involved if out-sourced activity for
• monitoring.
• Coordinate with investigator and sites for IM and assist PM in planning for IM
• Conduct SIVs, write SIV reports, and dispatch to sites
• Monitor sites, write monitoring visit reports and send timely monitoring follow-up letters to
• sites.
• Report SUSARs to regulatory authorities and all SAEs to sites, ECs, and investigators.
• Coordinate with data management team and investigator/site team for timely DCF resolution.
• Ensure CSR submission by investigator to EC, to regulatory authority (as applicable)
• Conduct site close-outs and write close-out reports and dispatch to sites.
• Arrange trial document archival at sites, in-house, and/or by third party as applicable.
• Revise SOPs and write new SOPs as applicable.
• Maintain and keep updated training file and CV for department records
• Assist PM in trial-related activities.

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