Clinical Research Associate Ii (cra Ii) – Fsp Business Unit
PPD (Thermo Fisher) UK
Fully remote
Risk-based monitoring approach
Ich-gcp guidelines compliance
On-site and remote monitoring visits
The role involves conducting remote or on-site visits to assess protocol and regulatory compliance while managing required documentation for clinical trials
Job Summary
The role involves conducting remote or on-site visits to assess protocol and regulatory compliance while managing required documentation for clinical trials.
Candidates will apply root cause analysis and critical thinking to identify site process failures and implement corrective actions to ensure data reliability.
This position requires maintaining regular contact with investigative sites to confirm protocol adherence and resolve previously identified issues expeditiously.
Matching Summary
The role involves conducting remote or on-site visits to assess protocol and regulatory compliance while managing required documentation for clinical trials.
Skills & Requirements
Must-have
Risk-based monitoring approach
ICH-GCP guidelines compliance
On-site and remote monitoring visits
Root cause analysis skills
Protocol and regulatory adherence
Nice-to-have
Critical thinking and problem solving
Collaborative relationship building
Effective oral and written communication
Adaptability in various scenarios
Process improvement contributions
Key Requirements
Bachelor's degree in life sciences or Registered Nursing certification
1 year of experience as a clinical research monitor