Clinical Research Associate II or Senior (FSP), Germany
Nr ref.: /JOBS.pl
* Perform site visits and monitor activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements. * Mentor CRAs on monitoring, internal procedures, and query resolution. * Use expertise and judgement to identify and resolve complex site issues and deficiencies in documentation, communication, and the need for additional training. * Assess and ensure overall integrity of study and adherence to guidelines, protocols, and regulations. * Evaluate overall performance of site and site staff. * Ensure compliance and understanding of study requirements by site staff. * Provide recommendations regarding site-specific actions and use judgment and expertise to assess ability of site staff. * Interpret data to identify protocol deviations or major risks to data integrity. * Understand project scope, budgets, and timelines and be able to provide input and manage project objectives to meet timelines. * Act as a liaison between the company and study site personnel and be able to respond to site concerns and questions. * Review and verify case report forms and other clinical data for completeness and accuracy. * Monitor patient safety and identify and address any protocol deviations and make appropriate recommendations. * Generate queries and manage resolutions with site staff. * Maintain project tracking systems as required. * Participate in the identification and selection of investigators and clinical sites. * Assist in the development of study specific monitoring procedures and guidelines. * Mentor junior staff on training, guidelines, and processes. * Complete assigned training programs and apply learning. * Maintain working knowledge of GCP/ICH Guidelines as well as applicable regulations. Education Required:Bachelor's degree or RN in a related field or equivalent combination of education, training and experience. Experience Required: * Experience/ proven track record in in-house support and monitoring * Extensive prior clinical monitoring experience * Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements * Strong organizational skills * Must demonstrate good computer skills. * Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade. * Heavy travel (up to 70%) In return we will offer: * A competitive remuneration package with excellent benefits. * A commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organisation. * The opportunity to work within a successful and rewarding environment.