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 involves frequent travel generally 60-80% with exposure to biological fluids and requires use of 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
Clinical monitoring skills
Risk-based monitoring approach
ICH-GCP guidelines compliance
Data accuracy through SDR and SDV
Clinical Trial Management System usage
Frequent travel up to 80%
Use of personal protective equipment
Nice-to-have
Critical thinking and root cause analysis
Good presentation skills
Effective interpersonal communication
Ability to work independently or in teams
Good organizational and time management skills
Good computer skills including Microsoft Office
Key Requirements
Bachelor's degree in life sciences or Registered Nursing certification
Minimum 1 year clinical research monitoring experience or PPD Drug Development Fellowship completion