Contract Clinical Research Associate, Oncology Canada
We’re actively seeking a contract Clinical Research Associate (CRA) with Oncology monitoring experience gained while working for a CRO or Sponsor, for an exciting opportunity supporting a global Partner known for consistent, on-time delivery and a strong track record across major therapeutic areas. Our Partner’s sites are located in Calgary and Edmonton, Alberta, so this role is open to CRAs based in either city. This is an onsite monitoring role requiring approximately 8 days on site per month, at about 30 hours a week, with an initial 6-month contract and the possibility of extension. We’re seeking CRAs who have a minimum of 5 years of recent experience as a fully dedicated regional/home-based field monitor for a CRO or pharma, at least 1 year of Oncology monitoring experience within the last 5 years, Phase II and/or Phase III monitoring experience, previous experience as a contract CRA, proximity to a major airport, and availability at 75% utilization. Inflammatory Bowel Disease (IBD) or GI monitoring experience is a strong plus. Apply below if this is you!
- Act as the "Site Manager" ensuring relationship with site(s) are positive, issues are resolved quickly, and communications are strong across all verticals.
- Assist with the development of study manuals, CRFs, monitoring standards, site study tools and other study materials as required.
- Develop and implement site recruitment, selection and initiation plan.
- Manage and drive patient recruitment and enrollment tracking.
- Provide training to sites on the study protocol, study conduct, CRF completion and data management expectations.
- Ensure essential document collection for completeness per regulatory requirements.
- Serve as a liaison with Investigators, Institutions and sites to provide support during the conduct of the clinical trial and serve as a resource for protocol and procedures.
- Demonstrate knowledge of on-site monitoring to ensure compliance with GCPs, study protocols, and SOPs.
Manage one or multiple studies. - Monitor product supplies/accountability including proper storage, dispensation, and disposal.
- Manage study completion activities including CRF collection, query resolution, record archiving and site closeout activities.
- Review in-house data and study tables.
- Mentor, coach and provide guidance to clinical staff as appropriate.
- Supervise and train other employees as appropriate.
- Minimum of 5 years’ experience as a fully dedicated regional, home based, field monitor for a CRO or pharma, within the last 2 years
- Minimum of 1 year of Oncology monitoring experience within the last 5 years
- Phase II and/or Phase III monitoring experience
- Previous experience as a contract CRA
- Nice to have: Inflammatory Bowel Disease (IBD) or GI monitoring experience
- Nice to have: Phase I monitoring experience
- Bachelor’s degree preferred
- Based in Calgary or Edmonton, Alberta, within an hour of a major airport, with no travel restrictions
- Availability for 75% utilization (about 30 hours a week)