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 site facilities and staff remain adequate for conducting a study. The role identifies investigators and verifies that they have the qualifications, resources, facilities, equipment, and staff needed throughout the study. Responsibilities also include training site staff, supporting regulatory and/or Ethics Committee submissions when applicable, and mentoring or training new staff, including 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.

Nice To Haves

  • Experience with complex trials in oncology or rare disease.

Responsibilities

  • Perform on-site or remote pre-study, initiation, interim, and close-out monitoring visits.
  • Ensure investigational site facilities and staff continue to be adequate for study conduct.
  • Identify investigators and verify their qualifications, resources, facilities, equipment, and staff.
  • Train investigational site staff as necessary.
  • Support preparation of regulatory and/or Ethics Committee submissions when applicable.
  • Participate in mentoring and training new staff.
  • Perform co-monitoring visits to assess junior staff performance.
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