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Parexel
Parexel Initiation Clinical Research Associate II Recruitment 2026: Apply Online
Initiation Clinical Research Associate II
Experience Required
3-4 Years
Salary / Package
Competitive
Work Mode
On-site
Openings
1
Job Overview
Parexel is seeking a dedicated Initiation Clinical Research Associate II to join our Hyderabad office on an on-site basis. In this role, you will be instrumental in supporting complex European Union Clinical Trials Register (EUCTR) submissions for Phase II and III clinical trials.
- Collaborate with Clinical Trial Management and Regulatory Affairs teams.
- Determine key study milestones and manage Part II Clinical Trial Application (CTA) planning.
- Maintain comprehensive contact details of participating Member States and Principal Investigators within the CTIS database.
- Ensure compliance with national regulatory requirements and handle Requests for Information (RFI) efficiently.
Key Job Details
| Company Name | Parexel |
| Job Role | Initiation Clinical Research Associate II |
| Experience | 3-4 Years |
| Salary Range | Competitive |
| Job Type | Full Time |
| Work Mode | On-site |
| Openings | 1 |
| Job Location | Hyderabad, India |
Key Responsibilities
- Coordinate multi-country regulatory documentation and submissions via the CTIS database.
- Ensure all Part II CTA submissions adhere to local and international regulatory standards.
- Manage Requests for Information (RFIs) from Member States and coordinate cross-functional responses.
- Track study-level and Member State-level milestones from initiation through enrollment.
- Archive trial-related documents securely in compliance with regulatory mandates.
Requirements & Qualifications
- Bachelor’s degree in a relevant discipline.
- 3 to 4 years of hands-on experience in CTIS, European Clinical Trials Regulation (EU-CTR), and study startup.
- Comprehensive working knowledge of ICH-GCP, EU/EMA, and IVDR guidelines.
- Demonstrated experience in handling multi-country clinical trial applications.
Required Skills
- Strong interpersonal and communication abilities.
- Exceptional attention to detail and organizational skills.
- Effective problem-solving capabilities in high-pressure regulatory environments.
- Self-starter mindset with high adaptability to change.
About Parexel
Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry, dedicated to bringing new treatments to patients faster.
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Frequently Asked Questions
Q: What is the primary role of an iCRA II at Parexel?
A: An iCRA II manages complex European Union Clinical Trial Register (EUCTR) submissions, regulatory compliance, and multi-country clinical trial applications.
Q: What qualifications are required for this role?
A: Candidates must hold a Bachelor’s degree and possess 3-4 years of experience in CTIS, EU-CTR, study startup, or clinical trial operations.
Q: Where is the job location?
A: The position is based in Hyderabad, India, operating on an on-site capacity.
Q: How can I apply for this position?
A: You can apply online by visiting the official Parexel career portal through the direct application link provided.
Q: What key regulatory knowledge is required?
A: Candidates are expected to have a strong understanding of ICH-GCP, EU/EMA, and IVDR regulatory guidelines.
Disclaimer: This job post is prepared by collecting data from the official career page of Parexel. We are not direct recruiters or representatives. Candidates should carefully review the requirements and policies on the company’s portal before initiating an application.