Apply for Parexel Hiring Freshers for iCRA II Remote Clinical Research Associate role supporting EUCTD and CTIS reporting across India with strong documentation responsibilities.
Parexel, a global leader in clinical research and regulatory services, has announced openings for the iCRA II role across India. This position is available in Bengaluru, Hyderabad, and Mumbai, with the flexibility of working fully remote. If you are a clinical research professional with experience in regulatory documentation, CTIS submissions, and EU clinical trial processes, this role provides exceptional career growth and international exposure.
The iCRA II role is designed for candidates who have a foundational understanding of the clinical development lifecycle and want to build a deeper specialization in European regulatory reporting. This long-format post provides full details of the job responsibilities, required skills, qualifications, and step-by-step instructions for how to apply.
About Parexel
Parexel is one of the world’s leading Contract Research Organizations (CROs), dedicated to improving global health outcomes through clinical research, regulatory support, consulting services, and market access strategies. Operating in more than 80 countries, Parexel partners with biotechnology, medical device, and pharmaceutical companies at every stage of drug development. Parexel Hiring Freshers for iCRA II Remote Clinical Research Associate
Every role at Parexel contributes to the development of therapies that help patients worldwide. The company values empathy, quality, integrity, and teamwork—ensuring employees feel a strong connection to the mission of advancing medicine. Parexel Hiring Freshers for iCRA II Remote Clinical Research Associate
Role Overview: iCRA II
The iCRA II position focuses on European Union Clinical Trials Directive/Regulation (EUCTD/R) reporting within the Clinical Trial Information System (CTIS). Candidates in this role will be responsible for planning, documenting, coordinating, and maintaining regulatory submissions for clinical trials conducted in EU Member States. Parexel Hiring Freshers for iCRA II Remote Clinical Research Associate
This role offers a mix of regulatory operations, document management, database entry, cross-functional coordination, and compliance oversight. Ideal candidates are highly organized, detail oriented, and well-versed in clinical development and regulatory requirements.Parexel Hiring Freshers for iCRA II Remote Clinical Research Associate
Key Responsibilities
The responsibilities of the iCRA II position revolve around EU regulatory processes and CTIS data handling. Below is a structured and detailed description of the work involved. Parexel Hiring Freshers for iCRA II Remote Clinical Research Associate
1. Operations Management
Planning Clinical Trial Applications (CTA)
The iCRA II collaborates with Regulatory Affairs representatives to plan and prepare Clinical Trial Applications for studies that involve EU countries. This includes identifying applicable regulatory requirements for each Member State.
Coordination with Clinical Trial Management (CTM)
You will work with CTM teams to understand study milestones, timelines, and country allocation strategies so that the clinical trial progresses in compliance with EU regulatory expectations. Parexel Hiring Freshers for iCRA II Remote Clinical Research Associate
Coordination with Clinical Transparency Teams
You will identify documents requiring redactions and coordinate with transparency teams to ensure that confidential information is appropriately handled before submissions. Parexel Hiring Freshers for iCRA II Remote Clinical Research Associate
Identifying Member States and Capturing Data in CTIS
Responsibilities include identifying participating EU Member States for each clinical trial and entering all related information into the CTIS database.
Tracking Study and Country-Level Milestones
You will document key trial milestones such as Study Start, Enrollment Start, Enrollment Completion, Study Completion, and any hold or restart dates that might apply.
Managing Site and Investigator Details
Each Member State’s list of institutions, sites, and primary investigators must be identified and recorded accurately.
Uploading CTA Documents
You will locate and upload required documents applicable at Member State, country, or site level for CTA submissions in the CTIS database.
Maintaining Consistent Information Across Study Lifecycle
As the study progresses, you will continuously update Member State participation lists, site details, and investigator information to ensure alignment across all systems.
Handling Queries (Requests for Information)
When regulatory authorities raise RFIs, you will triage, review, and coordinate responses to ensure issues are resolved efficiently.
Vendor Management
If external vendors assist with CTIS entries or document collection, you will oversee their contributions and ensure quality and accuracy.
2. Document Management
The document management responsibilities include:
- Performing document transfers
- Ensuring proper storage and archival of regulatory guidelines
- Tracking and filing documents to maintain compliance
- Supporting regulatory submission preparation
This role helps develop an in-depth understanding of global submission standards and foundational RA documentation principles. Parexel Hiring Freshers for iCRA II Remote Clinical Research Associate
3. Compliance with Parexel Standards
The iCRA II must comply with the organization’s internal standards, including:
- Completing all required training on time
- Submitting timesheets accurately
- Filing expense reports promptly
- Updating CV information as needed
- Maintaining effective communication across business functions
Strong adherence to compliance ensures smooth coordination between global teams and regulatory authorities.
Required Skills
To excel in the iCRA II role, candidates must demonstrate:
- Working knowledge of clinical drug development
- Understanding of ICH-GCP and regulatory guidelines
- Familiarity with EUCTD/R regulations
- Experience with Veeva Vault Clinical (CTMS, eTMF preferred)
- Strong multitasking and project management abilities
- Effective problem-solving and decision-making skills
- Excellent communication, both written and verbal
- Organized and detail-oriented working style
- Ability to synthesize large amounts of information
- Strategic and critical thinking
- Self-motivation in a fast-paced environment
- Ability to handle deadlines under pressure
- Strong command of MS Office tools
Some travel (up to 25 percent) may be required depending on study needs.
Knowledge and Experience
To qualify, candidates should have:
Experience
- 1 to 3 years of experience in clinical research
- Experience reviewing essential clinical documents
- Exposure to CTIS, CTA submissions, or regulatory documentation (preferred)
Education
- Bachelor’s degree in science, pharmacy, biotechnology, life sciences, health sciences, or related fields
This combination ensures that applicants can understand regulatory complexities and work efficiently with cross-functional clinical teams. Parexel Hiring Freshers for iCRA II Remote Clinical Research Associate
Why Join Parexel?
Parexel offers an exceptional environment for early to mid-career regulatory professionals. Benefits include: Parexel Hiring Freshers for iCRA II Remote Clinical Research Associate
- Working with international clinical trial teams
- Exposure to European regulatory frameworks
- Opportunities to grow within regulatory operations and submissions
- Well-structured training programs
- Supportive work culture emphasizing teamwork and empathy
- Fully remote work environment in India
- Opportunity to contribute to global drug development
Parexel’s commitment to employee development, learning, and well-being makes it an excellent long-term career choice. Parexel Hiring Freshers for iCRA II Remote Clinical Research Associate
How to Apply
To apply for the iCRA II position at Parexel:
- Visit the official Parexel Careers website.
- Search for Job Requisition ID: R0000036088.
- Select the location (Bengaluru, Hyderabad, or Mumbai – Remote).
- Click on the Apply button.
- Create or log in to your Parexel account.
- Upload your updated resume and complete the application form.
- Submit the application and monitor email communication for further steps.
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