Clinical Research Associate II

Agilus Consulting Group; Ottawa; Presencial; CAD 55.000 - 85.000; Jornada completa

Descripción de la vacante

Agilus by Synergie in Ottawa, Ontario is seeking a Clinical Research Associate II to support execution, monitoring, and regulatory compliance for medical device studies. You will coordinate with scientists, project managers, statisticians, and data managers while maintaining study documentation and TMFs in a fast-paced environment.

The ideal candidate holds a Science degree and 2+ years of clinical research or lab experience, with knowledge of GCP.

Formación

• Bachelor's degree in Science or equivalent experience.
• At least 2 years of clinical research or scientific laboratory experience.
• Veeva and TMF uploads are assets.
• Strong technical writing and documentation skills.
• Knowledge of Good Clinical Practice guidelines.

Responsabilidades

• Prepare study-specific clinical research documentation.
• Maintain Trial Master Files with accuracy and compliance.
• Develop and update standard operating procedures.
• Coordinate logistics and operational support for clinical studies.
• Conduct remote monitoring activities to support study execution.
• Collaborate with scientists, project managers, statisticians, and data managers.
• Support the analysis and reporting of clinical study results.
• Ensure study activities comply with quality and regulatory requirements.

Conocimientos

Strong technical writing

Attention to detail

Independent working

Team collaboration

GCP knowledge

Educación

Bachelor's degree in Science or equivalent experience

Herramientas

Veeva

TMF uploads

Descripción del empleo

Launch Your Clinical Research Career with an Innovative Medical Diagnostics TeamAgilus by Synergie is recruiting for a Clinical Research Associate II in the Medical Device field in Ottawa, Ontario. Are you passionate about clinical research and advancing healthcare technology? We are seeking a Clinical Research Associate to support the execution and monitoring of clinical studies for innovative point-of-care diagnostic testing products. In this role, you'll collaborate with cross-functional teams including scientists, project managers, statisticians, and data managers while contributing to study documentation, monitoring activities, and clinical trial operations in a fast-paced, highly regulated environment.

A typical day:

• Prepare study-specific clinical research documentation
• Maintain accurate and compliant Trial Master Files
• Develop and update standard operating procedures
• Coordinate logistics and operational support for clinical studies
• Conduct remote monitoring activities to support study execution
• Collaborate with scientists, project managers, statisticians, and data managers
• Support the analysis and reporting of clinical study results
• Ensure study activities comply with quality and regulatory requirements

Successful candidates will have:

• Hold a Bachelor's degree in Science or possess equivalent relevant experience
• Bring at least 2 years of clinical research or scientific laboratory experience
• Veeva and Trail Master File uploads is an asset
• Demonstrate strong technical writing and documentation skills
• Demonstrate knowledge of Good Clinical Practice guidelines

Soft skills:

• Communicate effectively through excellent verbal and written English skills
• Apply strong attention to detail and commitment to quality standards
• Work independently while contributing effectively within a team environment
• Adapt successfully to changing priorities in a fast-paced setting

Total rewards:$55000.00 - $85000.00 annually

• Work with innovative medical diagnostic technologies that impact patient care
• Gain exposure to all phases of clinical study execution and monitoring
• Develop expertise in clinical research and regulatory compliance processes