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
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