CRA 1/2, Sr. CRA – Oncology, General Medicine, French Speaking

Posted 3 weeks ago

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About the role

  • CRA position responsible for site monitoring in clinical trials, supporting various sponsors with a focus on oncology and general medicine. Fluency in French is desired, with travel across Canada.

Responsibilities

  • Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
  • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
  • Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
  • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document monitoring
  • Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested
  • Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
  • Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management
  • Assist with training of new employees, eg. co-monitoring
  • Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned
  • Perform other duties as assigned by management

Requirements

  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
  • 1 - 3+ years of Clinical Monitoring experience
  • Oncology or ophthalmology experience is desired
  • Open to various hub locations in Canada
  • French Speaking preferred

Benefits

  • Frequent travel to clients/ site locations with occasional travel both domestic and international
  • Health insurance
  • Professional development opportunities

Job title

Job type

Full Time

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

RemoteCanada

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