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%, 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 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
Good organizational and time management
Teamwork and independent work capability
Good presentation skills
Proficiency in Microsoft Office
Attention to detail
Key Requirements
Bachelor's degree in life sciences or Registered Nursing certification
Approximately 2 years clinical research monitoring experience