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Principal Clinical Research Associate/ Senior Clinical Research Associate
Há 2 horas
About CTI CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit What You’ll Do Serve as main CTI contact for assigned study sites. Conduct site visits (pre-study, site initiation, interim monitoring, and close-out) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP. Assist with study start-up activities, including feasibility, pre-study activities and site selection. Collect, review and track essential/regulatory documents. Participate in and complete all general and study specific training as required. Participate in investigator, client and project team meetings; may include presentations. Create and implement subject enrollment strategies for assigned study sites. Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials. Perform site management activities and provide ongoing updates of site status to Clinical Project Manager. Conduct remote monitoring and complete the related activities in accordance with study specific Monitoring Plan. Utilize systems and reports to track subject status, subject case report form (CRF) retrieval/source document review (SDV), regulatory documents, and IP. Assist with project-specific activities as member of Project Team Monitoring Plan. Participate 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 procedures. Where applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committees, Regulatory Authorities, and follow-up the evaluation process until approval is available. Provide regular updates to Sponsor/Client. Support in contract negotiation with study sites, Investigator payments and tracking of site payments. Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans. Identify anticipated site issues and implement corrective actions or escalate as appropriate. Liaise with Clinical Data Management for data cleaning activities. Serve as mentor/trainer for CRAs; may include conducting training/assessment visits. Function in the role of Lead CRA for assigned projects. What You Bring At least 5-8 years of clinical trial monitoring experience or equivalent experience. Fluent in English. Bachelor'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. Previous experience in conducting clinical research studies in hospital setting, pharmaceutical company or CRO. Fully eligible to work in Brazil (São Paulo, Rio de Janeiro, Rio Grande do Sul/Santa Catarina). Proficiency in Spanish is considered an asset. Why CTI? Structured mentoring program to support career progression. Tuition reimbursement and partnership with universities for training programs. Stable employment with no layoffs in 20-year history, work‑life balance, and annual cash bonuses. Recognition as one of the best places to work in Greater Cincinnati and top CROs. Global philanthropic program supporting local community efforts. Consistent double‑digit growth, investment in technology, and 95% annual retention rate. Focus on treatments for chronically and critically‑ill patients, making a difference. Important Note In light of recent increase in hiring scams, if you are selected to move onto the next phase, 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 ( 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. #J-18808-Ljbffr
