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 www.ctifacts.com What You’ll Do Serve as main CTI contact for assigned study sites Conduct 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 GCP Assist with or oversee 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 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 What You Bring 2-5 years clinical research experience as a CRA or related profession in Germany Life science background Excellent knowledge in ICH-GCP and regulatory requirement Experience in Transplant and AKI or oncology is a plus Fluent (Level B2 to C1) in spoken and written language in German and in English You need to be fully eligible to work in Germany. CTI does not offer any Sponsorship Why CTI? Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department. Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program. Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market. Important Note In 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