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 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
- Knowledge of monitoring procedures and basic understanding of the clinical trial process
- Fluent in local office language and in English, both written and verbal
- At least 2 years of Clinical Monitoring experience
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 a competitive salary and benefits package. Travel is required, approximately 60% of the time.
Physical Demands/Work Environment:
- Must be able to sit at a computer for long periods of time
- Must be able to use hands to finger, handle or touch objects, tools or controls, including a computer keyboard, for up to 8 hours per day
- Standard office and/or home working environment
- Clinical Research Unit and hospital environment (administrative only)
- Risk of eye strain
- Will involve outside of normal office hours as required by the role