Clinical Research Specialist

3 days ago

Bhavnagar, Gujarat, India beBeeClinical Full time ₹ 15,00,000 - ₹ 20,00,000

About Us:

We are a leading IT services company providing digital engineering and IT solutions to clients worldwide.

Our expertise lies in helping clients modernize their technology infrastructure, adopt cloud and AI solutions, and accelerate innovation.

The job requires collaboration with cross-functional teams to improve document accuracy and prompt effectiveness.

Key Responsibilities:

  • Author and analyze clinical trial documents.
  • Work with key clinical documents: Protocol, Informed Consent Form, Clinical Study Report, Summary of Clinical Safety/Efficacy, Access Evidence Dossier, Statistical Analysis Plan and more.
  • Create, validate, and refine prompts for AI-assisted document generation.
  • Apply knowledge of clinical trial phases, study design, and drug development.
  • Maintain compliance with global regulatory standards (FDA, EMA, ICH-GCP).
  • Utilize medical terminologies and ontologies for clarity and consistency.
  • Ensure quality control and timely delivery of assigned tasks.
  • Provide regular updates and flag risks to the project manager.

Required Skills and Qualifications:

  • Protocol
  • Informed Consent Form (ICF)
  • FDA
  • EMA
  • ICH-GCP

Benefits:

  • Hybrid work mode
  • Contract employment type
  • Immediate - 15 Days notice period
  • 2 Rounds of Technical Interview

Others:

  • Candidates should have 1 - 5 years of experience
  • Any graduation qualification is accepted

Please share your CV at sushma.n@people-prime.com

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