Clinical Research Associate

Hamilton Health Sciences • Hamilton, ON

1d

About The Position

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 regulatory requirements including entering study required patient assessment findings in the EHR within scope of practice. Performs other administrative duties as required.

Requirements

• Bachelor’s degree in a health or science-related discipline required
• 1-2 years previous related experience
• 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
• Ability to organize workload to meet deadlines and flexible when priorities change
• Follows health and safety policies and procedures to ensure a safe workplace for self and others

Nice To Haves

• Clinical Research Graduate Certificate preferred
• Certification as a Clinical Research Professional (SoCRA or ACRP) an asset
• Clinical research experience preferred
• Experience using electronic health records and data management software applications preferred

Responsibilities

• Extracting patient information from the electronic health record (EHR)
• Accurately and efficiently entering data into the sponsor provided electronic data capture (EDC) system
• Asking questions to clarify issues related to data integrity
• Applying knowledge of internal policies and procedures and national research regulations and guidelines to ensure research activities are carried out in a compliant manner
• Communicating patient-specific and/or protocol compliance issues to the Research Coordinator and Investigator, as applicable
• Coordinating and managing minimal risk, non-invasive and/or non-interventional clinical trials from activation to close out, adhering to the study protocol and regulatory requirements
• Entering study required patient assessment findings in the EHR within scope of practice
• Performing other administrative duties as required
• Push/pull carts with patient charts/case reports

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees