Parexel is hiring for the role of iCRA II (India – Remote), offering an excellent opportunity for clinical research professionals with 1–3 years of essential document review or CTA experience. This role plays a key part in EU Clinical Trials Regulation (EUCTR) compliance, CTIS submissions, and coordination across global clinical operations.

If you’re looking for a clinical research job in India, especially one involving regulatory submissions, CTIS, and EU trials, this position is a top choice.

⭐ Key Responsibilities

Operations & Regulatory Coordination

• Plan Clinical Trial Applications (CTA) for trials involving EU countries.
• Collaborate with Regulatory Affairs and Clinical Trial Management teams.
• Identify Member States, study milestones, and country allocation strategies.
• Manage CTIS database entries: study data, institutions, investigators.
• Upload country-level and site-level documents for EMA submissions.
• Coordinate with Clinical Transparency on document redactions.
• Track and maintain consistency of study information across lifecycle.
• Handle RFIs (Requests for Information) during CTA review cycles.
• Manage vendor interactions for CTIS tasks.

Document Management

• Perform file transfers, tracking, storage, and archival.
• Ensure compliance with global regulatory submission standards.

Compliance & Internal Standards

• Complete mandatory training and documentation.
• Maintain updated CV, timesheets, and expense records.
• Foster strong cross-functional relationships.

🎓 Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, or related field.
• 1–3 years of relevant experience in clinical documentation or regulatory operations.
• Knowledge of ICH-GCP, EUCTD/EUCTR, FDA regulations.
• Experience with Veeva Vault, CTMS, or eTMF.
• Strong analytical, communication, and stakeholder management skills.
• High level of organization and ability to manage multiple projects.

💼 Skills Required

• Clinical trial processes & regulatory guidelines
• Strategic thinking & problem solving
• Excellent written and verbal communication
• MS Office proficiency
• Ability to work in fast-paced environments
• Flexibility with up to 25% travel

🌟 Benefits of Working at Parexel

• Work-from-home (remote) opportunity
• Contribution to global health and patient care
• Exposure to EU CTIS and international clinical trial regulations
• Career growth in regulatory operations and clinical compliance
• Work with global teams across regulatory, clinical, and transparency functions

📌 How to Apply

Application Link