Synexus

About Synexus

Introduction Are you looking to play an integral role in the future of medicine across the globe? If so, this may be the opportunity for you! We are currently looking to attract a Site Compliance Specialist in Kiev. In this role you will provide quality control support to the clinical trial process by ensuring all study documentation and source data is accurately captured in CRF and up to date. You will be responsible for maintaining the Investigator Site Files (ISF) as well as performing quality checks and answering any CRF queries in a timely manner. The Role Key roles and responsibilities of the Site Compliance Specialist are: Act as a core study compliance lead on several studies to ensure the successful delivery of projects Participate in the start-up, set-up and close out of studies, ensuring adherence to the clients expectations Ensure accurate and timely entry of all data in the CRF Liaise with monitors and client representatives and complete the preparation for monitoring visit duties and audits Identify quality issues (QI) and reports on it, and supports and mentor junior compliance coordinators in this process Ensure adherence to rules and regulations of ICH. GCP and other regulatory and ethical guidelines as well as data protection regulations Responsible for audit preparation and ensure audit readiness of site files Identify trends in data queries The Person To be considered for this exciting opportunity you will need the following skills and experience: University education preferably in the field of Life-Sciences or related field Good understanding of theory and techniques in the data and compliance field Good multitasking and project management skills in order to oversee numerous studies with a variety of therapeutic areas and size simultaneously Solid understanding of quality compliance and ICH/GCP regulations Good interpersonal, leadership, consultative skills Good working knowledge of business English Solid MS Office Skills Good understanding of medical terminology Good time management skills Solid attention to detail Interested? Great, please apply now as we may close the advert earlier than the expiry date Synexus is an Affirmative Action and Equal Opportunity Employer. About The Company Accelerated Enrolment Solutions (AES) is a business unit of PPD that offers both sponsors and contract research organizations best-in-class site and enrolment solutions, with tiered offerings combining the expertise, as needed, of industry leaders PPD, Synexus, Acurian and Optimal Research. The array of integrated solutions includes PatientAdvantage, PPD’s global clinical development services optimized with Acurian and Synexus enrolment capabilities. Acurian and Synexus have proven track records for enrolling patients and study conduct through proprietary, direct-to-patient recruitment methodologies and a global site network. When combined, these services provide a new standard of clinical trial productivity that delivers more patients from fewer sites in less time. Package Description Competitive salary and benefits; interesting and stable job in a multinational company; open and friendly organizational culture; opportunity for training and professional development in the area of clinical trials

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