Description
We are seeking a Clinical Research Associate to join our team. As a Clinical Research Associate, you will have site management responsibility for clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, and applicable project plans and Sponsor requirements.
Key responsibilities include:
- 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 alongside applicable regulatory requirements
- Safeguarding data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines
- Confirming Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial
- Guaranteeing that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements
- Ensuring adherence to global quality control and CRA performance metrics
- Ensuring audit readiness at site level
- Acting 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
- 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
- A minimum of 2 years of Clinical Monitoring experience
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 preferred
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
- Travel Requirement is 60% of the time (travelling to study sites)