Site Activation Specialist supporting clinical trial start - up, regulatory submissions, and site activation for Syneos Health. Coordinating country - level quality, compliance, feasibility, and investigator contract activities.
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
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