Parexel has announced a new opportunity for the position of Initiation Clinical Research Associate II in Hyderabad, India. The role is focused on clinical trial site startup, EU Clinical Trials Regulation (EU-CTR), CTIS submissions, and European clinical trial operations.
This is an on-site, full-time opportunity for clinical research professionals with 3–4 years of relevant experience in study startup, CTIS, EUCTR, or clinical trial operations. Candidates with knowledge of ICH-GCP, EU/EMA regulations, IVDR, CTMS, eTMF, and European clinical trial submissions can apply.
Parexel Recruitment 2026 – Overview
| Particulars | Details |
|---|---|
| Company Name | Parexel |
| Job Role | Initiation Clinical Research Associate II |
| Functional Area | Clinical Trial Site Startup |
| Job Location | Hyderabad, Telangana |
| Work Mode | On-Site |
| Employment Type | Full-Time |
| Qualification | Bachelor’s Degree |
| Experience | 3–4 Years |
| Key Area | EU-CTR / CTIS / Study Startup |
| Application Mode | Online |
Job Summary
The Initiation Clinical Research Associate II will support the planning and execution of European clinical trial submissions and study startup activities for Phase II and Phase III clinical trials.
The role involves coordinating with Clinical Trial Management, Regulatory Affairs, and Clinical Transparency teams to manage Part II Clinical Trial Application (CTA) submissions, country and site documentation, CTIS database activities, and regulatory milestones across multiple European countries.
The selected candidate will play an important role in ensuring that clinical trials are started in accordance with regulatory requirements and project timelines.
Key Responsibilities
The selected candidate will be responsible for:
- Collaborate with Clinical Trial Management and Regulatory Affairs teams to establish study milestones and country allocation strategies.
- Support planning of Part II Clinical Trial Application (CTA) submissions for European countries.
- Identify participating Member States, institutions, and Principal Investigators for clinical trials.
- Collect and maintain detailed contact and site information in the CTIS database.
- Collect, organize, review, and upload country-level and site-level documents required for CTA submissions.
- Coordinate with Clinical Transparency teams regarding document redactions.
- Ensure Part II CTA submissions comply with applicable national requirements in participating Member States.
- Manage Requests for Information (RFI) by coordinating questions and responses between relevant stakeholders.
- Collect documents required for IVDR ethics submissions.
- Verify regulatory documentation against country-specific requirements.
- Monitor Part II submission progress and report status against study timelines.
- Maintain records of participating Member States, institutions, and investigators throughout the study lifecycle.
- Capture important study-level and Member State-level milestones in CTIS.
- Track milestones such as:
- Study Start
- Enrollment Start
- Enrollment Completion
- Study Holds
- Study Restarts
- Study Cancellations
- Ensure trial-related documents are appropriately archived according to regulatory and company requirements.
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Educational Qualification
Candidates should have:
- Bachelor’s Degree in Life Sciences, Pharmacy, Medicine, Nursing, or a related discipline.
Relevant education combined with clinical research experience may also be considered according to the company’s requirements.
Experience Required
Applicants should have:
- 3–4 years of relevant experience.
- Experience in one or more of the following areas:
- CTIS Database
- EU Clinical Trials Regulation (EU-CTR)
- Study Startup
- Clinical Trial Operations
- European Regulatory Submissions
Candidates with experience managing multi-country European clinical trial submissions will be particularly relevant for this position.
Required Skills
The ideal candidate should have knowledge and experience in:
- EU Clinical Trials Regulation (EU-CTR)
- Clinical Trials Information System (CTIS)
- EUCTR
- European Clinical Trial Submissions
- Study Startup Activities
- Clinical Trial Operations
- Part II CTA Submissions
- ICH-GCP Guidelines
- EU and EMA Regulatory Requirements
- IVDR
- CTMS
- eTMF
- Regulatory Documentation
- Site Documentation
- Clinical Trial Milestone Tracking
- Multi-Country Study Management
- Request for Information (RFI) Management
- Regulatory Compliance
- Stakeholder Coordination
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Work Location
Hyderabad, Telangana, India
Work Mode: On-Site
Candidates should be prepared to work from the Parexel Hyderabad office as this position is specifically advertised as an on-site opportunity.
Salary Details
Parexel has not officially disclosed the salary package for this position.
The actual compensation will depend on the candidate’s educational qualification, relevant clinical research experience, CTIS and EU-CTR expertise, technical skills, and interview performance.
Career Opportunity
This role provides an opportunity for clinical research professionals to specialize in European clinical trial startup and regulatory operations.
The selected candidate can gain valuable experience in:
- CTIS submissions
- EU-CTR compliance
- European regulatory processes
- Multi-country clinical trials
- Clinical Trial Application management
- Site startup
- Regulatory documentation
- Clinical transparency
- CTMS and eTMF systems
This experience can support future career growth in Clinical Operations, Study Startup, Regulatory Affairs, Clinical Trial Management, and European Regulatory Operations.
How to Apply
Interested and eligible candidates can apply online through Parexel’s official careers portal.
Candidates should ensure their resume clearly highlights:
- 3–4 years of relevant clinical research experience
- CTIS and EU-CTR knowledge
- European regulatory submission experience
- Study startup experience
- CTMS and eTMF experience
- ICH-GCP knowledge
- Multi-country clinical trial experience
Frequently Asked Questions (FAQs)
What is the job role at Parexel?
Parexel is hiring for the position of Initiation Clinical Research Associate II.
Where is the job located?
The position is based in Hyderabad, Telangana.
Is this a remote job?
No. The position is on-site.
How much experience is required?
Candidates should have 3–4 years of relevant experience in CTIS, EU-CTR, study startup, or clinical trial operations.
What is CTIS?
CTIS stands for Clinical Trials Information System, the European system used for managing and publishing information related to clinical trial applications and regulatory processes.
What regulatory knowledge is required?
Candidates should have knowledge of ICH-GCP, EU/EMA regulations, EU-CTR, and IVDR requirements.
Which systems are preferred?
Experience with CTIS, EUCTR, CTMS, eTMF, and site startup activities is required or preferred for the role.
