Clinical SME I

Oran • Herndon, VA

5d

About The Position

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.

Requirements

• Advanced degree preferred: MD, PharmD, RN, MPH, MS in Clinical Research or 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

Nice To Haves

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

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.

What This Job Offers

• Career Level: Senior