Clinical SME I

Clinical SME I

We are seeking a Clinical Subject Matter Expert (SME) with extensive experience in clinical trial operations FDA regulatory processes and protocol development. The ideal candidate will provide scientific and regulatory expertise supporting clinical research and healthcare initiatives.

• Review and analyze clinical trial protocols and regulatory documentation.
• Provide guidance on FDA regulatory requirements and ICH guidelines.
• Support protocol development study design and safety review processes.
• Evaluate inclusion/exclusion criteria endpoints and risk-benefit assessments.
• Collaborate with clinical regulatory and technical teams.
• Assist in pharmacovigilance and informed consent review activities.
• Provide subject matter expertise for healthcare and clinical research initiatives.
• Ensure compliance with applicable federal and clinical research regulations.

• Advanced degree preferred:
  • MD
  • PharmD
  • RN
  • MPH
  • MS in Clinical Research
  • Related clinical/scientific discipline
• Minimum 10 years of relevant clinical research or regulatory experience.
• Deep understanding of:
  • Clinical trial protocols
  • FDA regulatory review processes
  • Drug development lifecycle
  • Safety review
  • Protocol design

• Clinical protocol review
• ICH guidelines
• FDA regulatory processes
• Pharmacovigilance
• Study design
• Endpoint analysis
• Risk-benefit evaluation
• Informed consent review

• RAC (Regulatory Affairs Certification)
• Active clinical licensure preferred.