Remote Clinical Development Scientist

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Karius

πŸ’΅ $120k-$180k
πŸ“Remote - United States

Job highlights

Summary

Join Karius as a Clinical Development Scientist to design and execute clinical studies, collaborate with cross-functional teams, and develop study protocols. The ideal candidate will have a strong background in clinical research and molecular diagnostics.

Requirements

  • A Master's degree (in Public Health); a Ph.D. or MD is desired
  • 3 to 5 years of scientific/research background with experience in clinical research (preferably molecular diagnostics) conduct including methodology and statistics
  • Experience in scientific and clinical data review and interpretation
  • Project leadership and management skills

Responsibilities

  • Support the development of clinical protocols, amendments, case report forms, and data analysis interpretation
  • Conduct secondary research, including literature reviews to support study design
  • Assist in the preparation of study reports and other regulatory and/or reimbursement documents
  • Collaborate with the trial operations team on execution, and delivery of multiple clinical studies
  • Collaborate with biostatistics to develop and execute study statistical analysis plans
  • Ensure compliance with relevant regulations, guidelines, and SOPs
  • Help manage study data and maintain documentation
  • Participate in major written deliverables (e.g. protocols, clinical study reports, regulatory submissions, original articles, abstracts, posters and presentation materials) in collaboration with Medical and Clinical Affairs team members
  • Support the development of SOPs, policies and work instructions as part of continuous improvement initiatives
  • Actively participate in clinical study oversight, including monitoring study progress, ensuring compliance with regulatory requirements, and addressing any clinical issues that arise
  • Lead data interpretation sessions and assist in preparing clinical results for publication in peer-reviewed journals or conference presentations
  • Support the creation of regulatory documentation and submissions to ensure compliance with FDA and other regulatory bodies

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