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Initiation Clinical Research Associate I Job at Parexel

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Looking to build a strong career in clinical research startup roles? Parexel is hiring an Initiation Clinical Research Associate I (iCRA) in Bengaluru, India. This is an excellent opportunity for candidates with clinical trials start-up experience, regulatory submissions knowledge, and CTMS expertise.

Parexel, a global leader in clinical research and drug development, is known for delivering high-quality clinical trial solutions. If you have experience in site activation, IRB submissions, and TMF management, this role can significantly accelerate your career in clinical operations.

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Job Overview

  • Position: Initiation Clinical Research Associate I (iCRA)
  • Company: Parexel
  • Location: Bengaluru, India
  • Job Type: Full-Time
  • Application Deadline: May 8, 2026
  • Experience Required: Start-up or clinical research experience
  • Salary Range: โ‚น6,50,000 โ€“ โ‚น10,00,000 per annum (estimated)

Key Responsibilities

Clinical Trial Start-Up Activities

  • Manage site activation and pre-SIV activities
  • Handle IRB/IEC submissions and regulatory approvals
  • Coordinate Confidentiality Agreements (CDA) and Clinical Site Agreements (CSA)
  • Conduct remote Qualification Visits (QVs)

Regulatory & Documentation Management

  • Prepare and submit Informed Consent Forms (ICF) and amendments
  • Maintain Trial Master File (TMF) with First Time Quality (FTQ)
  • Ensure accurate updates in Clinical Trial Management Systems (CTMS)

Site & Stakeholder Management

  • Act as the primary contact for clinical trial sites
  • Build strong relationships with investigators and site staff
  • Resolve site issues related to compliance, training, and timelines

Compliance & Quality

  • Ensure adherence to ICH-GCP guidelines and regulatory standards
  • Maintain audit and inspection readiness
  • Monitor data quality and protocol compliance

Required Skills

  • Strong understanding of clinical trial start-up processes
  • Experience with CTMS, eTMF, and regulatory submissions
  • Excellent problem-solving and analytical skills
  • Ability to work in a matrix and global team environment
  • Strong communication and stakeholder management skills
  • High attention to detail and time management

Qualifications

  • Bachelorโ€™s degree in Life Sciences, Pharmacy, Nursing, or related field
  • Prior experience in clinical research or site start-up activities
  • Knowledge of IRB/IEC processes and clinical trial regulations

Why Join Parexel?

  • Work with a global CRO leader in clinical trials
  • Exposure to international regulatory processes
  • Opportunity to become a subject matter expert in clinical start-up
  • Collaborative and high-performance work culture
  • Career growth in clinical operations and project management

How to Apply

Application Link

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