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Clinical Research Specialist

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At the forefront of clinical research, a Medical Writer/Clinical Study Researcher plays a pivotal role in shaping the trajectory of drug development and regulatory submissions.

Key Responsibilities:
  • Document Development: Develop high-quality clinical trial documents, such as protocols, Investigator's Brochures (IBs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), and Clinical Study Reports (CSRs), ensuring strict adherence to regulatory requirements.
  • Scientific Communication: Craft compelling abstracts and manuscripts that demonstrate exceptional scientific communication skills, significantly contributing to the success of clinical research and regulatory submissions.
  • Protocol Design: Thoroughly comprehend study objectives and design protocols that meet and exceed regulatory expectations.
  • SOP Preparation: Prepare and review Standard Operating Procedures (SOPs) to ensure seamless documentation within tight project timelines.
  • Stakeholder Communication: Foster effective communication with stakeholders to guarantee complete and accurate documentation within established project deadlines.

A Medical Writer/Clinical Study Researcher is a critical member of the team responsible for developing high-quality clinical trial documents and communicating complex scientific data effectively.