Clinical Research Associate

Clinical Research Associate

Consultancy

Information

Do you want to make an impact as Clinical Research Professional? Do you want to protect the safety & well-being of subjects and guarantee data quality? Do you get energy from daily communication with investigators, study coordinators and study teams? Do GCP ICH E6 R2 and ISO 14155 have no secrets anymore for you? Do you like to perform monitoring visits in hospitals? Your responsibilities: * Initiates, monitors and closes study sites in compliance with procedural documents * Ensures that the rights and well-being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements * Proactively identifies study-related issues and finds the appropriate solutions independently or in cooperation with the study team lead * Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, legibility, completeness and quality of Case Report Form (CRF) in compliance with the protocol, SOP's and ISO/GCP requirements in order to ensure data integrity and subject safety * Carries out source data verification (SDV) according to the monitoring or SDV plan. * Ensures data query resolution What's in it for you? The QbD group is a healthy international company with strong growth ambitions (organic and inorganic). In addition to a competitive salary package, we can offer you: * The chance to acquire a broad knowledge in the fast-growing area of in vitro diagnostics * A company with a clear strategy and ambition * Develop your skills in a world class team of specialists * Value driven and data driven company * Award winning company More info? https://qbdgroup.com/en/vacancies/clinical-research-associate/
QbD Groupbooth 86-87-94-95The QbD Group supports life science companies worldwide throughout the entire product lifecycle – from idea to patient. We are a multinational company with over 480 high-qualified employees and are growing fast as we realise our ambitions of expanding worldwide. Our experienced team serves the wider life science industry, with a strong focus on ATMPs, medical devices, IVDs, and digital health, thanks to the specific expertise we have built in these areas. The services we offer fall under the following divisions: • Regulatory Affairs: We help our clients in their journey throughout the entire drug and medical device regulatory lifecycle. • Clinical: We are an expert clinical solutions provider specialized in medical devices and biotech, offering global CRO services and consultancy. • Qualification and Validation: We guarantee that products meet quality demands and comply with regulation through the qualification and validation of your processes, equipment, and software. • Quality Assurance: We offer the full range of QA services necessary to get your product to market in a safe and compliant way, including auditing from certified auditors, setting up your QMS, and all QP (Qualified Person) activities. • Lab Services: Our QC division consists of a GMP laboratory that offers analytical services for testing pharmaceutical raw materials, excipients, and release testing of finished products. • Software solutions & services: Cloud-based and pre-validated Quality Management Software built for the life sciences, as well as eIFU services which enable IVD and MD manufacturers to digitalize paper Instructions For Use (IFU). • Business & Communications: We help you launch your product to market by providing marketing and communication services, business development support, and sales strategy.

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