Clinical Research Monitor

Ozmosis Research Inc.; Greater Toronto Area; Remote; CAD 150,000 - 240,000; Full time

Job summary

An established industry player is seeking a Monitoring Manager to oversee clinical studies and ensure compliance with Good Clinical Practice (GCP) guidelines. This role involves remote work with travel to various investigational sites for on-site monitoring. The ideal candidate will have a strong background in clinical research, excellent communication skills, and the ability to work under pressure while maintaining attention to detail. This position offers a unique opportunity to contribute to important clinical studies in a dynamic and supportive environment, making a significant impact on patient safety and data quality.

Qualifications

• 2 years of experience in clinical research and/or oncology preferred.
• Previous on-site monitoring experience is an asset.

Responsibilities

• Monitor clinical studies ensuring compliance with protocols and GCP.
• Train site personnel on protocols and perform source data verification.
• Conduct pre-investigation visits, initiation, monitoring, and close-out visits.

Skills

Excellent written and verbal communication skills

Organizational skills

Attention to detail

Ability to work under pressure

Proficiency in English

Proficiency in French

Education

Bachelor’s degree in a science or health-related field

Post Graduate diploma in Clinical Research

Tools

Clinical trial management systems

Job description

Direct message the job poster from Ozmosis Research Inc.

Monitoring Manager at Ozmosis Research Inc.

The clinical research monitor is responsible for monitoring clinical studies and is a key contact for investigational sites from the pre-study visit until study closure. The monitor will work remotely and travel to various sites for on-site monitoring visits. The monitor is responsible for training site personnel on protocols, CRFs, Good Clinical Practice and performs source data verification while ensuring compliance with GCP guidelines, SOPs and the protocol. Other responsibilities include:

• Ensuring that studies are being conducted in accordance with study protocol, GCP and SOPs
• Performing source document verification of CRFs
• Conducting drug accountability/reconciliation
• Collection/Review of CRFs and regulatory documents
• Identifying/Resolving problems at the study site to ensure subject safety and data quality
• Conducting pre-investigation visits, initiation, monitoring and close-out visits

QUALIFICATIONS

Education:

• At a minimum, a completion of a Bachelor’s degree program in a science or health related field, or recognized equivalent required.
• Post Graduate diploma in Clinical Research preferred.

Experience:

• 2 years practical and related experience preferred
• 2 years of experience in clinical research and/or oncology preferred
• Previous on-site monitoring experience an asset.

Professional Affiliations/Memberships

• CCPE accreditation is an asset

Additional Skills & Functional/Technical Competencies:

• Proficiency in English
• Excellent written and verbal communication skills required in order to deal with staff from various centres
• Excellent organizational and prioritization skills, good computer skills, ability to learn quickly and independently
• Ability to perform duties in a professional and courteous manner and produce high quality work while meeting deadlines in accordance to Ozmosis standards.
• Exercise initiative and good judgment with ability to multi-task.
• Ability to work under pressure and close attention to detail
• Effective organizational, interpersonal and communication skills
• Knowledge of applicable legislative, regulatory and Ozmosis policies
• Proficiency in using clinical trial management systems
• Proficiency in French would be an asset but not required

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

• Industries

  Research Services

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