Clinical Research Associate

Job summary

The CRA is responsible for conducting various site visits, including initiation and monitoring, while ensuring adherence to FDA and ICH-GCP regulations. Key duties include data verification of source documents, regulatory document collection, and assisting with query resolution.

Job details

If you are an experienced CRA who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO is the place for you! Translational Research in Oncology (TRIO)is a global academic clinical research organizationdedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today. TRIO is looking for a Clinical Research Associateto join our Monitoring Resources team. Reporting to a CRA Line Manager, this position will be home-based in Eastern Canada. Responsibilities Conducting site visits, including pre-study, initiation, monitoring and termination; Confirmingadherence to all FDA, ICH-GCP and local regulations; Ensuring the completion and collection of regulatory documents; Performing data verification of source documents; Ensuring implementation and compliance with FDA, ICH-GCP guidelines; Participating in budget negotiation and follow-up where applicable; Assisting with data validation and query resolution; Mentoring junior team members as required. Qualifications: A minimum of 2 years of monitoring experience in oncology trials Fluent in English and French Experience monitoring phase 1 trials An advanced level of oncology knowledge Completion of a science-related Bachelor’s degree Excellent knowledge of medical terminology and clinical monitoring process Strong ICH-GCPs knowledge Experience with clinical trial information systems Ability to travel up to 60% on average Fluent in both English and French What TRIO Can Offer You: Competitive salary 3 weeks of vacation plus paid Christmas Closure 2 weeks paid personal/sick time Health, Dental, Vision & Life Insurance premiumspaid by TRIO Flexible working hours Monthly internet allowance Up to 5% RRSP Matching Program Pay Range $105,000.00 to $140,000.00annually - Salary to be influenced (or determined) by the education, experience, location, knowledge, skills, abilities of the applicant, internal equity, and alignment with market data.

What you’ll do

The CRA is responsible for conducting various site visits, including initiation and monitoring, while ensuring adherence to FDA and ICH-GCP regulations. Key duties include data verification of source documents, regulatory document collection, and assisting with query resolution.

Requirements

Candidates must have a science-related Bachelor's degree and at least 2 years of monitoring experience specifically in oncology trials, including phase 1. Fluency in both English and French and the ability to travel up to 60% are required.

Benefits

• 3 weeks of vacation • Paid Christmas Closure • 2 weeks paid personal/sick time • Health Insurance • Dental Insurance • Vision Insurance • Life Insurance • Flexible working hours • Monthly internet allowance • Up to 5% RRSP Matching Program

Listed skills

• French · Preferred
• Budget · Preferred
• Health · Preferred
• Data Validation · Preferred
• Compliance · Preferred
• Process · Preferred
• Negotiation · Preferred
• Time · Preferred
• future · Preferred
• Google Cloud · Preferred
• Flexible · Preferred
• English · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Clinical Monitoring
• Oncology Research
• ICH-GCP
• FDA Regulations
• Phase 1 Trials
• Data Verification
• Budget Negotiation
• Medical Terminology
• Clinical Trial Information Systems
• English Fluency
• French Fluency

Job areas

• Science & Research
• Healthcare