What a clinical research associate does
A clinical research associate, or CRA, monitors clinical trials on behalf of a sponsor or contract research organization. They qualify and open sites, train study staff on the protocol, visit sites in person or remotely to verify source data, check informed consent records and track investigational product, then document what they find and follow issues through to resolution. For a sponsor, good monitoring protects participants and produces data that will stand up when a regulator reviews the trial.
CRAs work under ICH Good Clinical Practice and, for drug trials in Canada, Part C, Division 5 of the Food and Drug Regulations, which governs clinical trial applications to Health Canada. Experience varies by therapeutic area, trial phase and the systems a sponsor uses, and many CRAs travel regularly or work from home across a region. Finch learns your studies, monitoring model and travel expectations, then searches in the GTA or nationally, depending on where your sites are.
Typical responsibilities
- Conduct site qualification, initiation, routine monitoring and close-out visits
- Verify source data against case report forms and raise data queries
- Review informed consent documentation and check participant eligibility
- Track investigational product accountability, storage and temperature records
- Write monitoring visit reports and follow up on protocol deviations
- Maintain the trial master file and support audit and inspection readiness
Qualifications and credentials
- A degree in life sciences, nursing, pharmacy or a related health field
- Current ICH GCP training, updated for the E6(R3) revision that Health Canada now applies
- Working knowledge of Division 5 of the Food and Drug Regulations and Health Canada clinical trial application requirements
- Experience with electronic data capture, clinical trial management systems and risk-based monitoring
- Professional certification such as ACRP's CCRA or SoCRA's CCRP, which some employers prefer
- A valid driver's licence and the ability to travel, for field-based roles
Who hires a clinical research associate
- Pharmaceutical and biotechnology sponsors
- Contract research organizations
- Medical device companies running clinical investigations
- Hospital research institutes and academic research centres
Where we recruit clinical research associate candidates
We fill clinical research associate roles for employers across Toronto and the GTA, including North York, Scarborough, Etobicoke, Vaughan, Markham, Richmond Hill, Mississauga, Brampton, Oakville, Burlington, Oshawa and Pickering, and for employers across Canada. GTA employers can meet us at our North York office by appointment.
What Finch checks before you meet a candidate
- Confirm monitoring experience by therapeutic area and trial phase
- Check that GCP training is current and documented
- Discuss on-site versus remote monitoring and the travel the role requires
- Ask how they have escalated serious protocol deviations or data integrity concerns
- Check references from clinical project managers or lead CRAs
Interview questions to ask
- During a monitoring visit you find a consent form signed after the first study procedure. What do you do?
- How do you prioritize source data verification under a risk-based monitoring plan?
- Tell me about a site that was falling behind on enrolment or data entry. How did you help them recover?