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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
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