Job Description

The Quality Risk Management Coordinator position is to drive the Quality Risk Management (QRM) processes for clinical research studies and to ensure compliance with ICH-GCP, PHRI SOPs and applicable regulations in order to uphold patient safety and the integrity of clinical research data. The Quality Risk Management Coordinator (QRMC) works closely with study teams in the initial stages of study planning to define Critical to Quality (CtQ) factors, quality tolerance limits and risk management strategies. The QRMC will also develop risk reports, for the Quality Assurance Department, that will inform quality assurance activities.

Qualifications * Undergraduate Degree in Science or Health related or equivalent.

2. ICH GCP; and National Regulatory Agency certificates (ICH \xe2\x80\x93 GCP, FDA, Health Canada and EMA) required.
3. Formal Clinical Research certification (i.e., SOCRA, ACRP) is highly recommended.
4. Minimum 3 years of work experience in Pharmaceutical and/or medical device clinical research required.
5. Minimum 2 years of experience Clinical Data Monitoring and Quality Risk Management required.
6. Demonstrated knowledge of the clinical development and risk-based central monitoring methodologies.
7. Understanding of Good Clinical Practices (GCP), both its principles and its practical application in a risk-based environment and Standard Operating Procedure Management.
8. Ability to work both independently and as part of a team.
9. Diplomacy and negotiating skills; ability to speak in front of others in both informal (working groups) and formal (training) settings.
10. Demonstrated ability to communicate clearly, in both oral and written formats, organized and ability to multi-task.
11. Computer systems knowledge of Microsoft Office applications

As a condition of employment, you are required to submit proof of full COVID-19 vaccination to Employee Health Services.

Hamilton Health Sciences