Job Description

The Clinical Research Associate (CRA) assists the research team by performing delegated study tasks for academic and pharmaceutical sponsored clinical trials with significant responsibility for data management. The CRA is responsible for extracting patient information from the electronic health record (EHR) and accurately and efficiently entering data into the sponsor provided electronic data capture (EDC) system. The CRA asks questions to clarify issues related to data integrity, and applies knowledge of internal policies and procedures and national research regulations and guidelines to ensure research activities are carried out in a compliant manner. The CRA communicates patient-specific and/or protocol compliance issues to the Research Coordinator and Investigator, as applicable. The CRA may coordinate and manage minimal risk, non-invasive and/or non-interventional clinical trials from activation to close out, adhering to the study protocol and requlatory requirements including entering study required patient assessment findings in the EHR within scope of practice. Performs other administrative duties as required.
Qualifications

• Bachelor's degree in a health or science-related discipline required
• Clinical Research Graduate Certificate preferred
• Certification as a Clinical Research Professional (SoCRA or ACRP) an asset
• 1-2 years previous related experience; Clinical research experience preferred
• Knowledge of medical terminology required
• Analytical thinking and problem solving skills
• Excellent written and verbal communication skills
• Knowledge of ICH-GCP guidelines, Health Canada Food and Drug Regulations, and Tri-Council Policy Statement 2 (TCPS-2)
• Basic knowledge of clinical research principles, practices, and processes related to project management, study coordination, regulatory requirements, data collection and reporting
• Highly proficient computer skills
• Experience using electronic health records and data management software applications preferred
• Ability to organize workload to meet deadlines and flexible when priorities change
• Ability to push/pull carts with patient charts/case reports
• Follows health and safety policies and procedures to ensure a safe workplace for self and others

Skills Required