Fortrea is a contract research organization (CRO) that provides advanced laboratory-focused services that help change lives. On a mission to deliver “life-cha
FSP CRAII
Location
China
Posted
9 days ago
Salary
0
Seniority
Mid Level
No structured requirement data.
Job Description
FSP CRAII
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).
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