[Hiring] CRA II @Fortrea

Role Description

• Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records.
• Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
• Prepares and implements project plans related to Clinical Monitoring responsibilities.
• Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.
• Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.
• Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.
• Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.
• Ensures adherence to global quality control and CRA performance metrics.
• Ensures audit readiness at site level.
• Acts in the project role of a Lead CRA as assigned.

Qualifications

• 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.

Requirements

• 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.

Preferred Qualifications Include

• Thorough working knowledge of Fortrea SOPs for site monitoring.
• One (1) or more additional years of experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
• Phase I monitoring experience.
• Life Science or Nursing qualification.
• Specific skills, systems, certifications, and/or licenses preferred.
• Personal characteristics (leadership, problem solving, interpersonal skills).
• Good attention to detail.
• Methodical approach to work.
• Good understanding of medical and clinical research terminology and clinical research processes.
• An understanding of the basics of physiology, pharmacology, and medical devices (when applicable).
• Good understanding of the principles of ICH GCP, ISO 14155 (if applicable) and local regulatory requirements.
• Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications.
• Good oral and written internal and external communication. Strong interpersonal team and organizational skills, personal presentation. The ability to communicate effectively in English.
• Focus on Customer.
• Innovate and Change.
• Pursue Scientific and Process Excellence.
• Work with Others.
• Achieve Results.
• Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors.
• Demonstrated ability to conduct clinical operations activities most effectively and efficiently.
• Good analytical and negotiation skills.
• Experience using e-clinical systems [e.g., clinical trial management system (CTMS)].
• For medical device positions, experience in providing customer service to device end users.

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).