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 the accuracy of 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
- 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
The role requires travel, including air travel, which is an essential function of the job. The ability to work with minimal supervision, good planning, organization, and problem-solving abilities are also necessary.
In return, we offer a competitive salary and benefits package.