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Pharmaceutical, Biotechnology, Clinical Research, Contract Research Organization (CRO)

Senior Clinical Research Associate

Toronto, ONOnsiteFull TimeSeniorPosted 15 days ago

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Required skills

  • SIV
  • RMV
  • COV
  • CRF review
  • source document verification
  • query resolution
  • site communication
  • site management
  • in-house support services
  • vendors

Nice to have

  • Oncology
  • freelance
  • travel
  • driver's license

Role summary

Seeking an experienced freelance Senior Clinical Research Associate (Sr. CRA) for onsite monitoring visits in Canada. Responsibilities include conducting SIV, RMV, and COV visits, performing CRF review, source document verification, and query resolution. The role involves site communication and management, acting as a liaison for support services and vendors, and communicating study progress to internal teams. The Sr. CRA will also participate in feasibility research, support regulatory submissions, and prepare for audits and inspections. A degree in Life Sciences or equivalent experience is required, along with independent onsite monitoring experience in Phase II/III trials. Proficiency in English and MS Office is essential. Experience in Oncology is a plus. Travel and a valid driver's license are necessary.

We are looking for an experienced freelance Sr. CRA to support us with the following responsibilities in Canada:

  • Conduct and report SIV, RMV, COV onsite monitoring visits
  • Perform CRF review, source document verification and query resolution
  • Be responsible for site communication and management
  • Be a point of contact for in-house support services and vendors
  • Communicate with internal project teams regarding study progress
  • Participate in feasibility research
  • Support regulatory team in preparing documents for study submissions
  • Prepare and particiapte on audits and inspections
  • College/University degree in Life Sciences or an equivalent combination of education, training & experience
  • Independent on-site monitoring experience
  • Experience in all types of monitoring visits in Phase II and/or III
  • Experience in Oncology is a plus
  • Full working proficiency in English.
  • Proficiency in MS Office applications
  • Ability to plan, multitask and work in a dynamic team environment
  • Communication, collaboration, and problem-solving skills
  • Ability to travel
  • Valid driver’s license

For this position, PSI is not hiring individuals who require work visa sponsorship for employment now or in the future.

This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global, mid-size company founded in 1995, we bring together more than 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

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