Clinical Research Associate (Canada)

About the role

IQVIA, a global provider of clinical research services, is hiring a Clinical Research Associate in Kirkland, Quebec. The role performs site monitoring and site management to make sure study sites run studies correctly and report data as required by the protocol, regulations and sponsor requirements.

Key responsibilities

• Carry out site monitoring visits (selection, initiation, monitoring and close-out) in line with the contracted scope of work and GCP and ICH guidelines.
• Work with sites to adapt, drive and track the subject recruitment plan so that recruitment is predictable.
• Deliver protocol and study training to assigned sites and keep regular contact to manage project expectations and issues.
• Evaluate the quality and integrity of site practices, escalate quality issues and track regulatory submissions, recruitment, CRF completion and data queries.
• Ensure site documents are available for the Trial Master File and that the Investigator's Site File is kept according to GCP, ICH and local regulations.
• Produce regular visit reports, follow-up letters and other study documentation, and liaise with the study team.
• If applicable, support the site-level recruitment plan and site financial management and invoice retrieval under the clinical trial agreement.

Required profile

• Bachelor's degree in a scientific discipline or health care, preferred; equivalent education, training and experience may be accepted.
• Some organizations require completion of a CRA training program or prior monitoring experience.
• Good therapeutic and protocol knowledge provided through company training.
• Written and verbal communication skills with a good command of English.

Required skills

• Basic knowledge of GCP and ICH guidelines and ability to apply them.
• Proficiency in Microsoft Word, Excel and PowerPoint, and use of a laptop, iPhone and iPad where applicable.
• Organizational, problem-solving, time and financial management skills.

The potential base pay range, annualized, is $72,100 to $152,500, depending on qualifications, location and schedule; incentives, bonuses and other compensation may also apply.