Clinical Research Associate Ii (cra Ii) – Fsp Business Unit
PPD (Thermo Fisher) UK
Remote, , UK
Fully remote
Clinical monitoring skills
Risk-based monitoring approach
Ich-gcp compliance
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 requires frequent travel generally 60–80% with possible extended overnight stays and involves maintaining audit readiness and developing collaborative relationships with investigational sites.
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 skills
Risk-based monitoring approach
ICH-GCP compliance
Data accuracy through SDR, SDV and CRF review
Remote and on-site monitoring
Microsoft Office proficiency
Frequent travel up to 80%
Nice-to-have
Critical thinking and root cause analysis
Effective communication skills
Organizational and time management skills
Interpersonal skills
Presentation skills
Ability to work independently or in a team
Adaptability and flexibility
Key Requirements
Bachelor's degree in life sciences or Registered Nursing certification
More than 1 year clinical research monitoring experience