Initiation Clinical Research Associate I (iCRA) – Parexel
Parexel is hiring an Initiation Clinical Research Associate I (iCRA) for its Clinical Operations team in Bengaluru. This opportunity is ideal for professionals with experience in Clinical Trial Start-Up, Site Activation, Regulatory Submissions, CTMS, eTMF, and Clinical Research Operations.
📋 Job Overview
| Particulars | Details |
|---|---|
| Position | Initiation Clinical Research Associate I (iCRA) |
| Company | Parexel |
| Location | Bengaluru, India |
| Job Type | Full-Time |
| Experience | 2–4 Years |
| Industry | Clinical Research / CRO |
🚀 Clinical Trial Start-Up Responsibilities
- Manage site activation activities.
- Handle pre-SIV activities and timelines.
- Coordinate IRB/IEC submissions.
- Support regulatory approval processes.
- Manage Confidentiality Agreements (CDA).
- Coordinate Clinical Site Agreements (CSA).
- Conduct remote Qualification Visits (QVs).
📑 Regulatory & Documentation Responsibilities
- Prepare and submit ICFs and amendments.
- Maintain Trial Master File (TMF).
- Ensure First Time Quality (FTQ).
- Update Clinical Trial Management Systems (CTMS).
- Manage essential regulatory documentation.
- Support inspection readiness activities.
🤝 Site & Stakeholder Management
- Act as primary contact for study sites.
- Build relationships with investigators and site staff.
- Resolve site activation issues.
- Support training and compliance activities.
- Coordinate with internal and external stakeholders.
🎓 Eligibility Criteria
- B.Pharm
- M.Pharm
- Life Sciences
- Nursing
- Healthcare Related Degree
💡 Required Skills
- Clinical Trial Start-Up
- Site Activation
- IRB / IEC Submissions
- CTMS
- eTMF / TMF Management
- Regulatory Submissions
- ICH-GCP
- Stakeholder Management
- Clinical Operations
🌟 Why Consider Parexel?
- Global CRO experience.
- International regulatory exposure.
- Career growth in Clinical Operations.
- Opportunity to specialize in Site Start-Up.
- Collaborative and learning-focused environment.
📈 Clinical Research Career Path
- Initiation Clinical Research Associate (iCRA)
- Clinical Research Associate (CRA)
- Senior CRA
- Lead CRA
- Clinical Trial Manager (CTM)
- Clinical Project Manager (CPM)
- Associate Director – Clinical Operations
- Director – Clinical Operations
📝 Resume Tips
- Highlight Site Start-Up experience.
- Mention IRB/IEC submission experience.
- Include CTMS and eTMF knowledge.
- Showcase TMF maintenance activities.
- Mention regulatory documentation experience.
- Highlight ICH-GCP knowledge.
- Keep resume ATS-friendly.
🎯 Interview Preparation Tips
- Revise Clinical Trial Start-Up processes.
- Understand IRB/IEC submission workflows.
- Review CTMS and eTMF concepts.
- Learn Site Activation timelines.
- Understand TMF documentation requirements.
- Revise ICH-GCP guidelines.
- Research Parexel and its global operations.
❓ Common Interview Questions
- What is Site Activation?
- What is the role of IRB/IEC in clinical trials?
- What documents are maintained in a TMF?
- What is CTMS?
- What is eTMF?
- What is the difference between CRA and iCRA?
- How do you handle site start-up delays?
- What are ICH-GCP guidelines?
- How do you prioritize multiple studies?
- Why do you want to join Parexel?
❓ Frequently Asked Questions (FAQ)
Q1. Which location is hiring?
Bengaluru, India.
Q2. What experience is required?
2–4 years of Clinical Research or Site Start-Up experience.
Q3. Which qualifications are eligible?
Life Sciences, Pharmacy, Nursing, Healthcare, and related disciplines.
Q4. Is CTMS experience required?
Knowledge of CTMS, eTMF, and regulatory submissions is preferred.
Q5. Is this a CRO role?
Yes, Parexel is one of the world's leading CROs.
📝 How to Apply
- Review the complete job description carefully.
- Update your resume with Site Start-Up and Clinical Research experience.
- Highlight CTMS, eTMF, TMF, and IRB/IEC submission experience.
- Apply only if your qualifications align with the role requirements.
- Keep your resume ATS-friendly and updated.
👉 Step-by-Step Guide: How to Apply for Healthcare & Pharma Jobs