Initiation Clinical Research Associate I (iCRA I) – Clinical Research Jobs in India | Parexel Careers 2026
Location: Bengaluru, India
Additional Location: Mumbai, India
Company: Parexel
Job Type: Full-Time
Industry: Clinical Research | CRO | Pharmaceutical Industry | Clinical Trials
Experience Required: Freshers or Minimum 2–5 Years of Clinical Research or Clinical Trial Start-Up Experience
Qualification: Life Sciences, Pharmacy, Nursing, Biotechnology, or Other Healthcare-Related Degree
About Parexel
Parexel is one of the world’s leading Clinical Research Organizations (CROs), dedicated to accelerating the development of innovative therapies and life-saving treatments. The company works with global pharmaceutical, biotechnology, and medical device organizations to deliver high-quality clinical trial solutions across multiple therapeutic areas.
At Parexel, Clinical Research Associates play a critical role in ensuring patient safety, protocol compliance, regulatory excellence, and successful clinical trial execution.
Initiation Clinical Research Associate I (iCRA I) Job Overview
Parexel is hiring an Initiation Clinical Research Associate I (iCRA I) for its Clinical Operations team in India. This role focuses on clinical trial start-up activities, site activation, regulatory submissions, IRB/IEC coordination, and investigator site management.
The selected candidate will work closely with investigators, sponsors, site personnel, regulatory authorities, and cross-functional global teams to ensure smooth study initiation and activation processes.
This opportunity is ideal for experienced clinical research professionals looking to build a long-term career in:
Clinical Trial Start-Up
Clinical Operations
Site Activation
Regulatory Affairs
Global Clinical Research Management
Key Responsibilities
Clinical Trial Start-Up & Site Activation
Manage study start-up activities from site identification to site activation
Serve as the primary point of contact for assigned investigator sites
Coordinate and manage Pre-SIV and activation-related tasks
Build professional relationships with investigators and site staff
Conduct feasibility assessments and remote qualification visits when required
Support execution of Confidentiality Agreements (CDA) and associated amendments
Track Clinical Site Agreement (CSA) timelines and coordinate with stakeholders
Regulatory & Ethics Submission Management
Prepare and submit IRB/IEC applications and regulatory submissions
Coordinate with Ministry of Health (MoH) and Regulatory Authorities (RA) where applicable
Manage protocol amendments and submission documentation
Ensure timely receipt of approvals and regulatory clearances
Customize and review country-specific Informed Consent Forms (ICFs)
Handle translation review and amendment negotiations as per regulatory requirements
Clinical Documentation & Compliance
Maintain Trial Master File (TMF) documentation with First Time Quality (FTQ)
Ensure study documents are audit and inspection ready
Update Clinical Trial Management Systems (CTMS) accurately and on time
Ensure compliance with:
ICH-GCP Guidelines
International and Local Regulatory Requirements
Parexel SOPs
Sponsor-specific procedures
Site Management & Operational Coordination
Support sites with access to study systems and project-specific training
Identify and resolve site-level operational risks and delays
Monitor study timelines and escalation points
Collaborate with global cross-functional teams for project delivery
Participate in internal and sponsor meetings
Required Skills
Technical Skills
Clinical Trial Start-Up Management
Site Activation Processes
Regulatory Submission Handling
CTMS & eTMF Systems
Clinical Documentation Review
ICH-GCP Knowledge
Microsoft Excel & MS Office Proficiency
Soft Skills
Strong communication and presentation skills
Problem-solving and analytical thinking
Excellent organizational abilities
Ability to work independently in a matrix environment
Cross-cultural collaboration skills
Attention to detail and compliance mindset
Time management and multitasking abilities
Eligibility Criteria
Educational Qualification
Candidates should possess any of the following:
B.Pharm
M.Pharm
Pharm.D
BSc / MSc Life Sciences
Biotechnology
Nursing
Other Healthcare or Biological Science Degrees
Experience Required
Minimum 2–5 years of experience in:
Clinical Research
Site Start-Up
Clinical Trial Operations
Regulatory Coordination
Site Activation Activities
Freshers are generally not eligible for this role due to the requirement for substantial start-up and clinical operations experience.
Why Join Parexel?
Working at Parexel offers professionals the opportunity to:
Work on global clinical trials
Gain international CRO exposure
Collaborate with global pharmaceutical sponsors
Develop expertise in clinical operations and regulatory processes
Build long-term career growth in the pharmaceutical and biotechnology industry
Career Opportunities After iCRA Experience
Professionals working as an Initiation CRA can progress into roles such as:
Clinical Research Associate (CRA)
Senior CRA
Site Activation Lead
Clinical Trial Manager
Regulatory Affairs Specialist
Clinical Operations Manager
Global Study Manager
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