Senior Clinical Research Associate

Job summary

Conduct and report onsite monitoring visits, review case report forms, verify source documents, resolve queries, and manage communication with clinical sites. Coordinate with internal teams and vendors, support feasibility research and regulatory submissions, and participate in audits and inspections.

Job details

Company Description PSI is a leading Contract Research Organization with 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description As a Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry. You will: Conduct and report SIV, RMV, COV onsite monitoring visits Perform CRF review, source document verification and query resolution Be responsible for site communication and management Be a point of contact for in-house support services and vendors Communicate with internal project teams regarding study progress Participate in feasibility research Support regulatory team in preparing documents for study submissions Prepare and particiapte on audits and inspections Qualifications College/University degree in Life Sciences or an equivalent combination of education, training & experience Independent on-site monitoring experience Experience in all types of monitoring visits in Phase II and/or III Experience in Oncology is a plus Full working proficiency in English and French is essential. Proficiency in MS Office applications Ability to plan, multitask and work in a dynamic team environment Communication, collaboration, and problem-solving skills Ability to travel Valid driver’s license Additional Information This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research. Compensation: CAD 120000 - CAD 150000 - yearly

What you’ll do

Conduct and report onsite monitoring visits, review case report forms, verify source documents, resolve queries, and manage communication with clinical sites. Coordinate with internal teams and vendors, support feasibility research and regulatory submissions, and participate in audits and inspections.

Requirements

A college or university degree in life sciences, or an equivalent combination of education, training, and experience, is required, along with independent onsite monitoring experience and experience across monitoring visit types in Phase II and/or III trials. Full working proficiency in English and French, Microsoft Office proficiency, strong planning, communication, collaboration, and problem-solving skills, willingness to travel, and a valid driver’s license are required; oncology experience is an asset.

Listed skills

• Site Communication · Preferred
• Planning · Preferred
• Multitasking · Preferred
• Microsoft Office · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Clinical Monitoring
• Site Management
• Source Document Verification
• CRF Review
• Query Resolution
• Site Communication
• Feasibility Research
• Regulatory Documentation
• Audit Preparation
• Inspection Preparation
• Oncology
• English Proficiency
• French Proficiency
• Microsoft Office
• Planning
• Multitasking
• Support Services
• Research Support
• Bilingual (French/English)
• Valid Driver's License
• Research
• Auditing
• Management
• Clinical Research
• Clinical Trials
• Communication
• Innovation
• Problem Solving
• Life Sciences
• Source Document

Job areas

• Healthcare
• Science & Research
• Clinical Research Associate
• Biologists, Botanists, Zoologists and Related Professionals
• Clinical Research Coordinators
• Natural Sciences Managers

More jobs from PSI CRO