Clinical Research Operations Analyst, Senior

Key Role:

Apply expert understanding of clinical studies and regulatory pathways for a government client. Oversee multiple clinical programs. Perform independent quantitative and qualitative data collection and analysis methods to derive insights on client issues, evaluate trends, and assess potential solutions. Develop and support or lead communications of practical solutions to clients in the form of data-driven presentations, briefings, and reports. Work in a fast paced environment with limited supervision.

Basic Qualifications:

  • 4+ years of experience in a professional work environment

  • 3+ years of experience in working with clinical trial research operations

  • Knowledge of medical product development, clinical trial operations and regulatory pathways

  • Ability to work in a team-based or project environment

  • Ability to lead projects or tasks

  • Ability to obtain a security clearance

  • BA or BS degree

Additional Qualifications:

  • 3+ years of experience with the health or medical product industries

  • 2+ years of experience in working with FDA regulated clinical trials

  • 1+ years of experience in project management

  • Experience with Institutional Review Board (IRB)

  • Possession of excellent analytical skills

  • Possession of excellent verbal and written communication skills

  • Secret clearance

  • MA or MS degree in Nursing, Health Administration, or Public Health

  • Project Management Professional (PMP) Certification

  • Regulatory Affairs Certification (RAC)

  • Certified Clinical Research Coordinator

  • Physician Assistant, Registered Nurse, or Licensed Practical Nurse

Applicants selected will be subject to a security investigation and may need to meet eligibility requirements for access to classified information.

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