Description
Fortrea is seeking a Clinical Research Associate to manage clinical studies according to their 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 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
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
- One or more additional years of experience in a related field
- Phase I monitoring experience
- Life Science or Nursing qualification
The role involves 60% travel to study sites, and the ability to work independently with minimal supervision.
Qualifications (Minimum Required)
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
- 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.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required)
- External Candidates: University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). AND A minimum of 2 years of Clinical Monitoring experience.
- Internal Candidates: Internal candidates with 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.
- Have an understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
- Good planning, organization, and problem-solving abilities.
- Works efficiently and effectively in a matrix environment.
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 (traveling to study sites).