As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation
Job Summary
As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation.
You will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability.
Work is performed in an office, laboratory, clinical, and/or home office environment with frequent travel generally 60-80%, including exposure to biological fluids and requiring personal protective equipment.
Matching Summary
As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation.
Skills & Requirements
Must-have
Risk-based monitoring approach
Protocol and regulatory compliance
Clinical Trial Management System
Root cause analysis and problem solving
On-site and remote monitoring
Data accuracy through CRF review
Frequent travel to site locations
Nice-to-have
Good presentation skills
Effective interpersonal skills
Ability to work independently or in team
Good organizational and time management
Attention to detail
Good oral and written communication
Customer focus and listening skills
Key Requirements
Bachelor's degree in life sciences or Registered Nursing certification
Minimum 1 year clinical research monitoring experience or PPD Fellowship completion