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.
The role 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
Regulatory and protocol compliance
Data accuracy through SDR, SDV and CRF review
Effective communication with medical personnel
Frequent travel to clinical sites
Nice-to-have
Critical thinking and root cause analysis
Problem-solving skills
Team collaboration and independent work
Good organizational and time management skills
Presentation and business writing skills
Adaptability and flexibility
Proficiency in 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