Pharm'Up 
PAREXEL, a global leader in biopharmaceutical services, is inviting applications for the position of initiation Clinical Research Associate (iCRA) II. This role is pivotal in the early stages of clinical trials, focusing on site startup, regulatory activations, and ensuring that clinical sites are “greenlighted” for patient recruitment.
Job Profile & Key Details
| Feature | Details |
| Post Name | initiation Clinical Research Associate (iCRA) II |
| Location | Bengaluru, India |
| Job ID | R0000036655 |
| Industry | Pharma / Healthcare / Clinical Research |
| Last Date to Apply | 20th February 2026 |
The Role of an iCRA II
The iCRA II is primarily accountable for the Start-up Phase (from site identification to site activation). Unlike a traditional CRA who monitors ongoing data, the iCRA ensures the foundation of the study is legally and regulatorily sound.
Key Responsibilities:
- Site Activation: Manage the strategy for Pre-Site Initiation Visits (SIV) and drive the activation timeline.
- Regulatory Submissions: Prepare and submit applications to IRB/IEC and MoH/Regulatory Authorities, resolving any conflicts to secure final approval.
- Documentation: Review and negotiate country-specific Informed Consent Forms (ICF) and manage the Trial Master File (TMF) to ensure “First Time Quality” (FTQ).
- Stakeholder Liaison: Act as the primary point of contact for investigators and site staff, building professional relationships to facilitate study delivery.
- Technical Management: Maintain and update the Clinical Trial Management System (CTMS) and ensure sites have access to necessary study systems.
Candidate Requirements
- Education: * Degree in Pharmacy (B.Pharm/M.Pharm), Biological Sciences, or other health-related disciplines.
- Equivalent nursing qualifications or clinical research experience are also considered.
- Experience: * Substantial experience in Clinical Trial Start-up or equivalent clinical research experience.
- Deep understanding of clinical trial methodology, terminology, and ICH-GCP guidelines.
- Technical Skills: * Proficiency in CTMS and eTMF software.
- Strong analytical skills for autonomous decision-making in ambiguous situations.
- Excellent communication and negotiation skills for contract and ICF management.
How to Apply
Interested candidates meeting the eligibility criteria should apply via the PAREXEL Careers Portal using the Job ID: R0000036655. Ensure your application is submitted before the deadline on 20th February 2026.
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