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Clinical Research Associate (Cra) – Clinical Monitoring & Site Management

Innovaderm Research
Innovaderm Research
2-3 years
preferred by company
Noida, India
1 May 12, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill

Clinical Research Associate (CRA) – Clinical Monitoring & Site Management

Company: Innovate Research
Job Title: Clinical Research Associate (CRA)
Location: Noida, India
Experience Required: 2–3 Years
Employment Type: Full-Time


About the Role

Innovate Research is looking for a dedicated and detail-oriented Clinical Research Associate (CRA) to join its Clinical Operations team in Noida. This opportunity is ideal for professionals with experience in Clinical Trial Monitoring, Site Management, Regulatory Compliance, and Clinical Research Operations.

The selected candidate will be responsible for monitoring clinical trial activities, ensuring protocol compliance, maintaining site documentation, and supporting high-quality execution of clinical studies in accordance with ICH-GCP and regulatory guidelines.

This role is best suited for candidates with 2–3 years of Clinical Research and site monitoring experience.


Key Responsibilities

Clinical Trial Monitoring

  • Conduct:
    • Site Qualification Visits (SQV)
    • Site Initiation Visits (SIV)
    • Interim Monitoring Visits
    • Site Close-Out Visits
  • Ensure clinical trials are conducted according to:
    • Study protocols
    • ICH-GCP Guidelines
    • Regulatory requirements
  • Monitor site performance and identify compliance risks

Site Management & Documentation

  • Maintain and review:
    • Investigator Site Files (ISF)
    • Trial Master File (TMF)
    • Essential clinical trial documentation
  • Ensure timely and accurate documentation updates
  • Coordinate with investigators and site staff for study-related activities

Clinical Data Review & Query Resolution

  • Perform:
    • Source Data Verification (SDV)
    • Source Document Review (SDR)
    • CRF review activities
  • Verify accuracy and completeness of clinical trial data
  • Support query generation and resolution activities

Patient Safety & Regulatory Compliance

  • Ensure informed consent procedures are properly documented
  • Monitor patient safety and protocol adherence
  • Identify and escalate:
    • Protocol deviations
    • Safety concerns
    • Compliance issues
  • Support audit and inspection readiness activities

Cross-Functional Collaboration

  • Collaborate with:
    • Clinical Operations teams
    • Investigators
    • Sponsors
    • Regulatory teams
  • Participate in study meetings and training sessions
  • Support timely study execution and milestone achievement

Educational Qualification

Candidates should possess one of the following qualifications:

  • B.Pharm / M.Pharm
  • Pharm.D
  • B.Sc / M.Sc in Life Sciences
  • Biotechnology
  • Nursing
  • Related healthcare or clinical research discipline