Clinical Research Associate I

TL;DR

Clinical Research Associate I (Medical): Delivering quality monitoring reports and ensuring the validity of clinical data collected at assigned sites. Focus on data integrity, subject safety, and compliance with ICH GCP/ISO14155, protocol, and client requirements.

Location: Canada

Company

hirify.global helps biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics.

What you will do

• Deliver quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan (CMP) timelines.
• Ensure the validity, correctness, and completeness of clinical data reviewed and collected at assigned sites.
• Monitor (remote, on site or other approved mode of monitoring) with a focus on data integrity and subject safety.
• Plan day-to-day activities for monitoring of a clinical study and set priorities per site.
• Prepare for and conduct on site and/or remote qualification, study initiation, interim monitoring, dosing observation, and close out monitoring visits as directed per CMP.
• Proactively manage site visits and trial issues during the monitoring phase.

Requirements

• Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution.
• Patient facing, study coordinating experience preferred.
• Knowledge of ICH-GCP/ISO14155, FDA Guidance Documents, EU Directives, local/regional regulations, and drug/device development and clinical monitoring procedures.
• Knowledge of clinical/health systems as well as knowledge of cultural/professional practices appropriate to the country/region where site monitoring activities will be conducted.
• Ability to multitask and work effectively with technology and people in a fast-paced environment with changing priorities, self-starter.
• Travel up to 70-85%.
• Fluency in French is required

Culture & Benefits

• Opportunity to grow and excel at work with flexibility and balance.
• Ideas influence the way we work, and your voice matters here.
• Essential part of our team, you help us deliver the medical innovation that patients are desperate for.