Ogłoszenie, którego szukasz jest nieaktywne.

Administracja biurowa » Pracownik biurowy

  • Województwo zagranica
  • Miejscowość inne


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. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

Ciekawe oferty z tego działu:
Praca - Niemcy - Pomoc kuchenna/ kelnerka
Poszukiwana osoba na stanowisko pomoc kuchenna bądź kelnerka do kuchni azjatyckiej w mieście Herzogenaurach - Bawaria 1300 euro na rękę + zakwaterowanie + pożywienie. 8 godzin dziennie, 6 dni w...
Zobacz także >>
Porady ekspertów - zobacz artykuły
Szkolenie na profesjonalną opiekunkę do dziecka
Szkolenie na profesjonalną opiekunkę do dziecka
Już od 10 listopada Fundacją Ad Fontes powinna zanteresować się każda osoba, która pragnie podwyższyć swoje kwalifikacje jako opiekunka do dziecka. Szkolenie nie jest jednak skierowane tylko do...

Proszę czekać - ładowanie treści...