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 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 and site management
risk-based monitoring approach
ICH-GCP guidelines compliance
protocol and regulatory compliance
data accuracy through SDR and SDV
frequent travel to site locations
effective communication with medical personnel
Nice-to-have
critical thinking and root cause analysis
problem-solving skills
good organizational and time management
ability to work independently or in a team
good presentation skills
attention to detail
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