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.
You will facilitate effective communication between investigative sites, the client company and the PPD project team and respond to company, client and applicable regulatory requirements/audits/inspections.
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
Clinical trial site management
Regulatory and ICH-GCP compliance
Data accuracy through SDR, SDV and CRF review
Clinical Trial Management System usage
Remote and on-site monitoring visits
Nice-to-have
Critical thinking and root cause analysis
Effective communication skills
Problem-solving skills
Team collaboration and independent work
Good presentation skills
Attention to detail
Key Requirements
Bachelor's degree in life sciences or Registered Nursing certification
1-2 years clinical research monitoring experience
Knowledge of ICH GCPs and applicable regulations
Completion of PPD Drug Development Fellowship or equivalent