Position Title

Clinical SME I

Overview

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.

Key Responsibilities

• 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.

Required Qualifications

• 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

Required Skills

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

Preferred Qualifications

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