Clinical Research Associate II
Fortrea
full-time
Posted on:
Location Type: Hybrid
Location: Sydney • Australia
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About the role
- Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements.
- Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP.
- Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to.
- Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines.
- Guarantees that the study Investigational Product inventory and accountability is accurate and stored securely.
- Ensures audit readiness at site level.
- Acts in the project role of a Lead CRA as assigned.
Requirements
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
- Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.
- Thorough knowledge of monitoring procedures.
- Basic understanding of the clinical trial process.
- Fluent in local office language and in English, both written and verbal.
- Typically 2 years of onsite clinical monitoring experience.
Benefits
- Health insurance
- Retirement plans
- Flexible working arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
site managementsite monitoringsource document reviewsource document verificationquery generationdata integrityaudit readinessclinical trial processmonitoring proceduresinformed consent procedures
Soft Skills
communicationleadershiporganizational skills
Certifications
nursing licensuredegree in allied health profession