About The Position

The Senior Clinical Research Associate performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visits to ensure investigational sites and staff remain adequate for conducting clinical studies. The role identifies investigators and verifies their qualifications, resources, facilities, equipment, and staffing throughout the study. It also trains site staff, supports regulatory and/or ethics committee submissions when applicable, and mentors or trains new staff, including conducting co-monitoring visits to assess junior staff performance.

Requirements

  • College or university degree in Life Sciences, or an equivalent combination of education, training, and experience.
  • Extensive on-site monitoring experience in Phase 2/3 trials.
  • Full working proficiency in English.
  • Ability to plan, multitask, and work in a dynamic team environment.
  • Communication, collaboration, and problem-solving skills.
  • Ability to travel nationally.
  • Good English language skills.

Nice To Haves

  • Experience with complex trials in oncology or rare disease is ideal.

Responsibilities

  • Perform on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visits.
  • Ensure investigational site facilities and staff remain adequate for study conduct.
  • Identify investigators and verify their qualifications, resources, facilities, equipment, and staff throughout the study period.
  • Train investigational site staff as necessary.
  • Support preparation of regulatory and/or EC submissions when applicable.
  • Mentor and train new staff.
  • Perform co-monitoring visits to assess junior staff performance.
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