
Clinical Study Document Specialist
2 days ago
Clinical Study Document Specialist
Role OverviewThis is a critical role requiring expertise in crafting high-quality documents that support clinical research and regulatory submissions.
The ideal candidate will have strong communication skills and attention to detail, with the ability to deliver accurate and well-structured documents within tight timelines.
Key Responsibilities:- Develop key clinical trial documents, including protocols, Investigator's Brochures (IBs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), and Clinical Study Reports (CSRs).
- Translate complex scientific data into clear, regulatory compliant documents.
- Prepare protocols, CSRs, Patient Information Sheets - Informed Consent Forms (PIS-ICFs) and CRFs.
- Understand study objectives and design protocols.
- Review and prepare SOPs.
- Communicate effectively with stakeholders to ensure timely documentation delivery.
Our team is committed to delivering exceptional results, and we are seeking a dedicated professional to join us in this mission.
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