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Parexel is hiring an iCRA II (Initiative Clinical Research Associate II) in Bengaluru, India. This is a high-impact clinical research role focused on study start-up, regulatory submissions, TMF/eTMF management, and site activation. If you have strong experience in clinical trial start-up activities and want to work with a global CRO committed to improving patient outcomes, this opportunity is highly relevant.
At Parexel, every role directly contributes to advancing therapies that benefit patients worldwide. The organization is known for its strong quality culture, compliance with ICH-GCP, and collaborative global environment.
📍 Job Overview
- Job Title: iCRA II
- Company: Parexel
- Location: Bengaluru, Karnataka, India
- Job Type: Full-time
- Experience Level: Mid-level (Clinical Research Start-Up)
- Application Deadline: 19 January 2026
- Requisition ID: R0000036655
🧪 Key Responsibilities – iCRA II Role
🔹 Start-Up Phase (Site Identification to Activation)
- Act as Parexel’s primary point of contact for assigned investigational sites.
- Manage site feasibility, qualification, and start-up activities.
- Prepare, negotiate, and execute Confidentiality Agreements (CDAs).
- Conduct remote qualification visits (QVs) when required.
- Coordinate Clinical Site Agreement (CSA) timelines with stakeholders.
- Customize, review, and negotiate Informed Consent Forms (ICFs) and translations.
- Prepare and submit IRB/IEC and MoH/Regulatory Authority applications.
- Ensure First Time Quality (FTQ) of documents in TMF/eTMF.
- Forecast and manage site activation timelines and regulatory approvals.
- Maintain accurate and timely updates in CTMS.
🔹 Maintenance Phase (Initiation to Close-Out)
- Manage regulatory amendments and ongoing IRB/IEC submissions.
- Maintain TMF completeness and inspection readiness.
- Ensure continuous compliance with ICH-GCP and local regulations.
🔹 Overall Accountabilities
- Ensure assigned sites are audit- and inspection-ready.
- Proactively identify and escalate risks related to timelines, compliance, or data quality.
- Collaborate in a matrix and virtual team environment.
- Mentor junior team members and contribute as a subject matter expert over time.
🎓 Qualifications & Experience Required
✅ Education
- Bachelor’s degree or higher in Pharmacy, Life Sciences, Biological Sciences, or related healthcare discipline
- Nursing qualification with equivalent clinical research experience is also acceptable
✅ Experience & Knowledge
- Substantial experience in clinical trial start-up activities
- Strong understanding of clinical trial methodology and terminology
- Hands-on experience with CTMS, eTMF, and regulatory submissions
- Knowledge of ICH-GCP, IRB/IEC processes, and Indian regulatory requirements
✅ Key Skills
- Strong problem-solving and decision-making abilities
- Excellent written, verbal, and interpersonal communication
- High attention to detail and time management skills
- Ability to work independently with minimal supervision
- Client-focused mindset and cross-cultural collaboration skills
💼 Salary & Benefits (Indicative)
- Estimated Salary Range: ₹10,00,000 – ₹16,00,000 per annum (CTC)
- Competitive compensation aligned with CRO industry standards
- Exposure to global clinical trials and multinational sponsors
- Strong learning, mentoring, and career progression opportunities
- Inclusive and performance-driven work culture
(Final compensation depends on experience, skills, and internal benchmarks.)
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📝 How to Apply
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