Clinical Research Associate II

About The JobThis position is responsible 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). Serves as main CTI contact for assigned study sites.What You'll DoConduct 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 while adhering to all applicable regulatory requirements, SOPs and ICH GCPAssist with 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 meetingsCreate 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 the 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 TeamMay support in development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.)May support in the translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis and other study applicable documents as per required proceduresWhere applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision 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/ ClientWhere applicable, support in 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 site issues and implement corrective actions or elevate as appropriateLiaise with Clinical Data Management for data cleaning activitiesAssist in preparing and coordinating Investigator and client meetings and attend meetings as necessaryWhat You BringAt least 2 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 CROImportant 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 a @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 NoteWe 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.#J-18808-Ljbffr