Senior Initiation Clinical Research Associate

About the role

We are seeking an Initiation Clinical Research Associate (iCRA) specializing in Pre-SIV and Activation tasks to join our team in India-Bengaluru capacity on a hybrid / on-site basis. As an iCRA, you will drive the strategy and execution of study startup, Pre-SIV, and activation activities while serving as Parexel's primary point of contact with assigned clinical sites.

What you'll do

• Support country-specific feasibility and site qualification activities, including preparation, negotiation
• Manage country and site-level Trial Master File (TMF) issues, ensuring First Time Quality (FTQ) documentation and providing direct resolution to reported site problems
• Develop and execute strategy for configuring, distributing, collecting, and reviewing high-quality country-specific and site-specific regulatory documents
• Customize, review, and negotiate country/site-specific Informed Consent Forms (ICFs), translations, and amendments within regulatory parameters
• Prepare and submit IRB/IEC and MoH/RA applications, resolving conflicts and determining appropriate follow-up until receipt of final approval

What you need

• Clinical research
• Documentation
• Site execution
• Communication
• GNM

Good to have

• Regulatory affairs