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 to conduct clinical studies. The role verifies that investigators have the qualifications, resources, facilities, equipment, and staff needed throughout a study, and trains site staff as necessary. When applicable, the role also supports preparation of regulatory and/or ethics committee submissions. The Senior Clinical Research Associate contributes to team development by mentoring and training new staff and 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.

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 facilities and staff remain adequate for the conduct of the study.
  • Identify investigators and verify their qualifications, resources, facilities, equipment, and staffing throughout the study period.
  • Train investigational site staff as necessary.
  • Support preparation of regulatory and/or ethics committee submissions when applicable.
  • Mentor and train new staff.
  • Perform co-monitoring visits to assess junior staff performance.
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