💼 Parexel Hiring: Initiation Clinical Research Associate (iCRA II) | Remote India | 1–3 Years
📍 Location: Remote – India
🎓 Eligibility: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Life Sciences
🧪 Experience: 1–3 Years (CTA / Essential Docs / Regulatory Ops)
📝 Job Type: iCRA II | Clinical Operations | Regulatory Submissions | Full-Time | Work From Home
🔎 Verified: ✅ Verified Job via Medical Jobs India – hitechplus.in
📄 Job Overview
Parexel is recruiting Initiation Clinical Research Associate (iCRA II) for remote positions across India. This role involves CTA planning, CTIS submissions, EUCTR regulatory tasks, document upload, lifecycle tracking and cross-functional coordination for global clinical trials.
🔬 Key Responsibilities
- ✔ Plan Clinical Trial Applications (CTA) for EU studies.
- ✔ Coordinate with Regulatory Affairs & CTM teams.
- ✔ Identify Member States and country allocation strategy.
- ✔ Manage CTIS entries: institutions, investigators, study data.
- ✔ Upload site-level & country-level documents for EMA submissions.
- ✔ Track study information consistency across lifecycle.
- ✔ Handle RFIs during CTA review cycles.
- ✔ Support document transparency and redaction activities.
- ✔ Maintain essential documentation, archival, and regulatory compliance.
✅ Qualifications & Requirements
- ✅ Bachelor’s degree in Life Sciences, Pharmacy, or related field.
- ✅ 1–3 years in CTA, SSU, eTMF, or regulatory documentation.
- ✅ Knowledge of EUCTR, ICH-GCP, FDA regulations.
- ✅ Experience in Veeva Vault, CTMS, eTMF preferred.
- ✅ Strong communication & stakeholder management skills.
- ✅ Ability to manage multiple tasks and timelines.
🎁 Why Join Parexel?
- 🌍 100% Remote work opportunity in India.
- 💰 Competitive compensation & global exposure.
- 📈 Work on EU clinical trials & CTIS submissions.
- 🤝 Work with global regulatory & clinical operations teams.
- 🏆 Career growth in regulatory & clinical compliance roles.
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🟢 Verified Job via Medical Jobs India – hitechplus.in
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