Description
We are seeking a Clinical Research Associate to manage clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, and Sponsor requirements.
The successful candidate will be responsible for:
- Conducting site monitoring responsibilities for clinical trials, including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits
- Preparing and implementing project plans related to Clinical Monitoring responsibilities
- Ensuring the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to
- Safeguarding data integrity through source document review, source document verification, query generation, and resolution
- Confirming Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current
- Guaranteeing accurate Investigational Product inventory and accountability
- Ensuring adherence to global quality control and CRA performance metrics
- Ensuring audit readiness at site level
- Acting as a Lead CRA as assigned
The ideal candidate will have:
- A university or college degree, or certification in a related allied health profession
- Thorough understanding of ICH GCP Guidelines and 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
Preferred qualifications include:
- Thorough working knowledge of Fortrea SOPs for site monitoring
- Additional years of experience in a related field
- Phase I monitoring experience
- Life Science or Nursing qualification
In return, you will receive:
- Competitive salary
- Opportunity to work on a variety of clinical trials
- Collaborative and dynamic work environment
This role requires 60% travel to study sites.