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Experience Level
Mid to Senior
Qualifications
Qualifications:Bachelor's degree in Life Sciences or an equivalent combination of education, training, and experienceProven independent on-site monitoring experienceExperience in conducting all types of monitoring visits during Phase II and/or III clinical trialsPrior involvement in clinical projects as a Lead or Senior MonitorSpecialization in Oncology is preferredFluent in both English and FrenchProficient in MS Office applicationsStrong ability to plan, multitask, and thrive in a dynamic team environmentExcellent communication, collaboration, and problem-solving skillsWillingness to travel as requiredValid driver's license (if applicable)
About the job
As a Senior Clinical Research Associate (CRA), you will act as a pivotal communication link with project stakeholders, ensuring that clinical research projects meet timelines, targets, and high standards across various therapeutic areas. Your expertise will be crucial in fostering and nurturing relationships with clinical sites and investigators. Your primary focus will be on safeguarding subjects' rights, ensuring their safety and well-being, and maintaining strict compliance with data quality standards.
This position offers a home-based opportunity within Quebec, Canada.
Key Responsibilities:
Conduct comprehensive onsite monitoring visits and report findings
Assist in study startup procedures
Perform CRF review, source document verification, and query resolution
Oversee site communication and management
Supervise study activities, timelines, and schedules at the country level
Act as a primary contact for in-house support services and vendors
Participate in quality control efforts, including compliance monitoring and reports review
Engage in feasibility research
Support the regulatory team in preparing documentation for study submissions
About psicro
psicro is a premier Contract Research Organization with over 30 years of industry experience, striking a perfect balance between stability and innovation for both clients and employees. We are dedicated to delivering high-quality and timely services across a broad spectrum of therapeutic indications.
AbCellera is seeking an International Clinical Study Manager based in Montreal to coordinate global clinical trials for new therapeutic products. This position involves direct oversight of studies across multiple countries, with a focus on keeping projects on track and aligned with regulatory requirements. Role overview The International Clinical Study Manag…
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As a Senior Clinical Research Associate (CRA), you will act as a pivotal communication link with project stakeholders, ensuring that clinical research projects meet timelines, targets, and high standards across various therapeutic areas. Your expertise will be crucial in fostering and nurturing relationships with clinical sites and investigators. Your primary focus will be on safeguarding subjects' rights, ensuring their safety and well-being, and maintaining strict compliance with data quality standards.This position offers a home-based opportunity within Quebec, Canada.Key Responsibilities:Conduct comprehensive onsite monitoring visits and report findingsAssist in study startup proceduresPerform CRF review, source document verification, and query resolutionOversee site communication and managementSupervise study activities, timelines, and schedules at the country levelAct as a primary contact for in-house support services and vendorsParticipate in quality control efforts, including compliance monitoring and reports reviewEngage in feasibility researchSupport the regulatory team in preparing documentation for study submissions
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