Clinical Safety Officer
About The Position
The Clinical Safety Officer oversees the safety of clinical trial participants during study conduct and maintains safety equipment. The role performs work in compliance with study protocols, Good Clinical Practices (GCP), and Standard Operating Procedures (SOPs). It includes clinical trial activities such as continuous monitoring, safety assessments, Investigational Product (IP) administration, and catheter installation, as well as monitoring and following up on participant adverse events. The officer also mentors and may train Clinical Operations team members, supports quality and customer service, communicates study progress and issues, and identifies opportunities to improve safety.
Requirements
- Degree from an accredited Registered Nurse, Paramedic, or equivalent program.
- Good communication skills.
- For the Montreal location, French and English communication skills.
- Customer-service focus and ability to work in a fast-paced environment.
- Must be legally authorized to work in the United States without employer sponsorship now or in the future.
Nice To Haves
- Related work experience is preferred.
Responsibilities
- Perform scheduled inspections of emergency crash carts, inspect and inventory their contents, and maintain up-to-date records.
- Mentor Clinical Operations team members.
- Ensure the confidentiality of clinical trial participants and sponsors.
- Continuously assess safety improvement opportunities and communicate them to departmental management.
- Perform clinical trial activities, including 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 related to their job needs.
- Provide feedback to appropriate team members regarding study progress, where necessary.
- Proactively communicate issues and/or problem resolutions to departmental supervisors and managers.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Education Level
No Education Listed
