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 that the study Investigational Product inventory and accountability is accurate
- 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
- A minimum of 2 years of Clinical Monitoring experience
- Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines
- Ability to work with minimal supervision
Preferred qualifications include:
- Thorough working knowledge of Fortrea SOPs for site monitoring
- One (1) or more additional years of experience in a related field
- Phase I monitoring experience
- Life Science or Nursing qualification
- Specific skills, systems, certifications, and/or licenses
- Good attention to detail, methodical approach to work, and good understanding of medical and clinical research terminology
The physical demands of this role include:
- Sitting at a computer for long periods of time
- Using 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
- Travel Requirement is 60% of the time (traveling to study sites)