Clinical Trial Document Specialist

2 days ago

Coimbatore, Tamil Nadu, India beBeeClinical Full time ₹ 72,00,000 - ₹ 1,80,00,000
Job Title: Clinical Research Associate

About the Role:

We are seeking a highly skilled and experienced Clinical Research Associate to join our team. The ideal candidate will have a strong background in clinical research, with expertise in protocol development, informed consent forms, and regulatory compliance.

The successful candidate will be responsible for authoring and analyzing clinical trial documents, working with key clinical documents such as protocols, informed consent forms, clinical study reports, and summary of clinical safety/efficacy. They will also create, validate, and refine prompts for AI-assisted document generation, apply knowledge of clinical trial phases, study design, and drug development, and maintain compliance with global regulatory standards.

In addition to these responsibilities, the Clinical Research Associate will utilize medical terminologies and ontologies for clarity and consistency, ensure quality control and timely delivery of assigned tasks, collaborate with cross-functional teams to improve document accuracy and prompt effectiveness, and provide regular updates and flag risks to the project manager.

Key Responsibilities:

  • Author and analyze clinical trial documents.
  • Work with key clinical documents.
  • 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.
  • Utilize medical terminologies and ontologies for clarity and consistency.
  • Ensure quality control and timely delivery of assigned tasks.
  • Collaborate with cross-functional teams.
  • Provide regular updates and flag risks.

Required Skills and Qualifications:

  • Experience in clinical research, preferably in protocol development, informed consent forms, and regulatory compliance.
  • Strong understanding of clinical trial phases, study design, and drug development.
  • Excellent communication and collaboration skills.
  • Ability to work in a fast-paced environment and meet deadlines.

Benefits:

  • Opportunity to work with a leading company in the industry.
  • Competitive salary and benefits package.
  • Professional development opportunities.

Others:

This is a contract position, requiring immediate start with 15 days' notice period.

Interviews will be held via two rounds of technical interviews.

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