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About The JobResponsible for project activities associated with monitoring functions of Phase I through Phase IV clinical research studies and Real World Evidence (RWE) studies, while continuing to develop knowledge of drug development process, International Council for Harmonisation (ICH) / Good Clinical Practice (GCP), and relevant regulations. Performs management of study site activities in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).What You’ll DoServe as main CTI contact for assigned study sitesConduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV])and complete site visit deliverables with quality and within given timelines in Monitoring Plan whileadhering to all applicable regulatory requirements, SOPs and ICH GCPAssist with or oversee study start-up activities, including feasibility, pre-study activities and site selectionCollect, review and track essential/regulatory documentsParticipate in and complete all general and study specific training as requiredParticipate in investigator, client and project team meetings; may include presentationsCreate and implement subject enrollment strategies for assigned study sitesEnsure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materialsPerform site management activities and provide ongoing updates of site status to Clinical Project ManagerConduct remote monitoring and complete related activities in accordance with study specific Monitoring PlanUtilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IPAssist with project-specific activities as member of Project TeamParticipate in the development of CRFs and other study related documents (subject worksheets,Monitoring Plan, etc.)Perform translation, customization, and review of Patient Information sheet and Informed Consent,protocol synopsis and other study applicable documents as per required proceduresWhere applicable, support or oversee contract negotiation with study sites, Investigator payments and tracking of site paymentsManage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring PlansIdentify and anticipate site issues and implement corrective and preventive actions or escalate as appropriateLiaise with Clinical Data Management for data cleaning activitiesServe as mentor / trainer for CRAs; may include conducting training/assessment visitsWhere applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation orrevision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is available. Provide regular updates to Sponsor/ ClientFunction in the role of Lead CRA for assigned project(s) Required Education And ExperienceAt least 3 years of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human ResourcesBachelor’s Degree or higher in allied health field such as nursing, pharmacy, or health / natural science,or RN with Associate’s Degree, or 3-year Nursing Diploma with at least 2 years clinical nursing experience, or equivalent experience as determined by CTI Management and Human ResourcesPrevious experience in conducting clinical research studies in hospital setting, pharmaceutical company or CROHas transplant and rare disease experience, experience in pulmonary studies is a plusWilling to travel 6 – 8 days per monthLives in Northern England (Liverpool, Leeds, Nottingham, Manchester, …) or ScotlandAvailability to travel outside of UK (for example: able to travel to Ireland without issues).COMPETENCIESExcellent verbal and written communication skillsExcellent organizational and time management skillsExcellent critical thinking and decision-making skills; proactively identify challenges and potential risksExcellent collaboration, customer service, and interpersonal skillsAbility to work independentlyProficient in use of laptop computer and software systems, including Clinical Trial Management (CTMS), electronic Trial Master File (eTMF), electronic Data Capture (EDC), or similar systemsAbility to understand complex medical terminology and proceduresAbility to monitor complex indicationsExpert knowledge of ICH/GCP and all applicable regulatory requirementsAbility to mentor and provide constructive feedback to lesser experienced CRAsImportant NoteIn light of recent increase in hiring scams, if you’re selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.Please Note We will never communicate with you via Microsoft Teams or text message.We will never ask for your bank account information at any point during the recruitment process.
