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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NH Case Processing Associate-Accenture 2 - 6 yrs Chennai

Perform single case medical assessment, including the determination of seriousness, expectedness / listedness / labeledness, and causality of adverse events in compliance with current regulations, internal and external guidance documents, Standard Operating Procedures, Safety Job Aids, the Argus User Reference Guide and case processing /coding conventions.

Maintain the timely submission of expedited reports.

Support the achievement of the Therapeutic Areas case processing performance timelines. Identify cases that meet SUSAR reporting criteria, prepare the SUSAR narrative, perform risk assessment, initiate the unblinding process (as appropriate), and make the report available for distribution.

Identify and evaluate safety signals based on individual cases and cumulative data assessment and by using other signal detection systems. Provide data-driven decisions and communicate these findings proactively and effectively to the key stakeholders.

Partner with Worldwide Safety Strategy and with other Worldwide Safety and Regulatory Safety Operations functional groups to monitor the safety profile of assigned products.

Actively participate in Risk Management Committees and other risk management activities for assigned therapeutic areas. Perform product safety reviews as appropriate.

Provide medical safety input as appropriate to Clinical Development Teams regarding expectedness /listedness/ labeledness, causality, and data reconciliation.

As appropriate, provide medical safety input, and review or draft sections of response documents to health authority inquiries.

Work with the Therapeutic Area Head to proactively and effectively communicate product safety issues and proposed solutions to PSSR management and to the Office of the EU Qualified Person.
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