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Clinical Trial Document Specialist

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Job Summary

A Medical Writer/Clinical Study Researcher is required to develop high-quality clinical trial documents, including protocols, Investigator's Brochures (IBs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), and Clinical Study Reports (CSRs).

  • Key Responsibilities:
  • Protocol Development: Develop key clinical trial documents, including protocols, IBs, ICFs, CRFs, and CSRs.
  • Scientific Communication: Translate complex scientific data into clear, regulatory compliant documents that support drug development and approval processes.
  • Document Preparation: Craft abstracts and manuscripts, demonstrating strong scientific communication skills.
  • Quality Assurance: Deliver high-quality, accurate, and well-structured documents that contribute to the success of clinical research and regulatory submissions.
  • Study Support: Prepare protocols, CSRs, PIS-ICFs, and CRFs.
  • Study Objectives: Understand study objectives and design protocols.
  • SOP Management: Prepare and review SOPs.
  • Stakeholder Engagement: Communicate with stakeholders to ensure effective and complete documentation within the timeline.
Requirements

Required skills and qualifications include:

  • Experience in developing high-quality clinical trial documents.
  • Strong scientific communication skills.
  • Ability to translate complex scientific data into clear, regulatory compliant documents.
  • Excellent document preparation skills.
  • Strong quality assurance skills.
  • Ability to prepare protocols, CSRs, PIS-ICFs, and CRFs.
  • Understanding of study objectives and design protocols.
  • Ability to prepare and review SOPs.
  • Strong stakeholder engagement skills.
Benefits

The ideal candidate will have experience in clinical trial document development and strong scientific communication skills.

Additional Information

The successful candidate will be able to work effectively in a team environment and communicate complex scientific data to various stakeholders. A degree in a life science or related field is preferred.