Clinical Safety Officer
Altasciences
Summary
The Clinical Safety Officer will oversee the safety of clinical trial participants during study conduct and the maintenance of safety equipment. The Clinical Safety Officer will execute tasks performed in compliance with study protocol, Good Clinical Practices (GCP) and Standard Operating Procedures (SOP)s.
Job description
About The Role
The Clinical Safety Officer will oversee the safety of clinical trial participants during study conduct and the maintenance of safety equipment. The Clinical Safety Officer will execute tasks performed in compliance with study protocol, Good Clinical Practices (GCP) and Standard Operating Procedures (SOP)s.
What You'll Do Here
- Perform scheduled inspection of emergency crash carts, inventory/inspect the contents and maintain up to date records.
- Act as a mentor to Clinical Operations team members.
- Ensure the confidentiality of clinical trial participants and sponsors is respected.
- Continuously assess safety improvement opportunities and communicate to departmental management.
- Perform clinical trial activities including but not limited to, continuous monitoring, safety assessments, Investigational Product (IP) administration and catheter installation.
- Monitor, document and/or follow-up on participant adverse events.
- May coordinate Basic and Advanced Life Support courses for Clinical Operations team members.
- Maintain and advocate a high level of customer service, quality and safety within the department.
- May train employees on clinical trial activities associated to their jobs needs.
- Provide feedback, where necessary, to appropriate team members of study progress.
- Proactively communicate issues and/or problem resolutions to departmental supervisors and managers.
What You'll Need to Succeed
- Degree from accredited Registered Nurse, Paramedic or equivalent program required. Related work experience preferred.
- Good Communication (French and English for Montreal location)
- Customer service focused, able to work in fast-paced environment.
Requirements
- Degree from accredited Registered Nurse, Paramedic or equivalent program required
- Related work experience preferred
- Good communication skills
- Customer service focused
- Able to work in fast-paced environment
Company overview
Altasciences is a forward-thinking, mid-size contract research organization (CRO) and contract development manufacturing organization (CDMO) that provides integrated, full-service solutions for early phase drug development. Founded in 1992 and owned by Novo Holdings A/S, the company offers pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies. Their comprehensive services include preclinical safety testing, clinical pharmacology and proof of concept studies, bioanalysis, formulation development, manufacturing and analytical services, program management, medical writing, biostatistics, and data management. With over 1,800 employees across eight facilities in the U.S. and Canada, Altasciences has established itself as a trusted partner for drug development from lead candidate selection through clinical proof of concept and beyond. The company's integrated CRO/CDMO model enables seamless transitions between development phases, reducing complexities, mitigating risks, and accelerating timelines for clients ranging from startups to global pharmaceutical leaders.