Clinical Research Documentation Specialist

3 days ago


Jodhpur, Rajasthan, India beBeeDocumentation Full time ₹ 18,00,000 - ₹ 25,00,000

Clinical Research Documentation Specialist

Job Overview:

We are seeking a highly skilled Clinical Research Documentation Specialist to join our team. As a key member of our clinical research operations, you will be responsible for developing high-quality documentation that supports drug development and approval processes.

Key Responsibilities:
  • Protocol Development: Create accurate and well-structured protocols that align with regulatory requirements.
  • Clinical Study Reports (CSRs): Develop comprehensive CSRs that showcase the results of clinical trials.
  • Investigator's Brochures (IBs) and Informed Consent Forms (ICFs): Design clear and concise IBs and ICFs that ensure transparency and informed decision-making by participants.
  • Case Report Forms (CRFs) and Supporting Documents: Prepare CRFs and supporting documents that facilitate efficient data collection and analysis.
  • SOP Development and Review: Contribute to the development and review of Standard Operating Procedures (SOPs) that ensure compliance with regulatory standards.
  • Stakeholder Communication: Effectively communicate with cross-functional teams to ensure timely delivery of high-quality documentation.
Required Skills and Qualifications:

To succeed in this role, you should possess:

  • Proficiency in Clinical Trial Document Development: Experience in creating high-quality clinical trial documents, including protocols, IBs, ICFs, CRFs, and CSRs.
  • Strong Scientific Writing Skills: Ability to translate complex scientific data into clear, regulatory-compliant documents.
  • Attention to Detail: Meticulous attention to detail to ensure accuracy and quality in all deliverables.
  • Effective Communication: Excellent communication skills to collaborate effectively with stakeholders.
Benefits:

This role offers:

  • Opportunities for Professional Growth: Chance to work on high-profile clinical research projects and develop your skills in document development and regulatory compliance.
  • Collaborative Work Environment: Join a dynamic team of professionals who share your passion for clinical research and excellence in documentation.
  • Competitive Compensation and Benefits: Enjoy a competitive salary and benefits package that recognizes your expertise and contributions.


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