(Senior) Clinical Research Associate - CRA - Warsaw

Posted on Mar 15, 2019 by Docs Global (Continental Europe)

Warsaw, Warsaw Poland
Research & Development
12 Mar 2019
Annual Salary
Full-Time
Job Summary DOCS has partnered with a highly prestigious organisation with one of the most robust pipeline within the industry. We have a great job opportunity for a Clinical Research Associates who are ready to further develop their career and enjoy working for a global organisation in their offices in Warsaw Roles & Responsibilities of the position Clinical Research Associate is the person in Trial Co-ordination and Site Management that serves as primary contact point between the sponsor and the investigational site. Responsibilities include site selection, pre trial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out. Partner with the CTA, LTM and GTM to ensure overall site management while performing trial related activities for assigned protocols. May contribute to process improvement, training and mentoring of other CRAs Responsibilities: • Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team • Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out • Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target. • Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct. • Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented. • Ensures site staff complete the data entry and resolve queries within expected timelines. • Ensures accuracy, validity and completeness of data collected at trial sites • Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents • Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints) • Fully documents trial related activities in particular monitoring. Job Requirements - minimum 1 years experience as an on-site CRA - Willingness to travel with occasional overnight stay away from home. - Proficient in speaking and writing the country language and English. Good written and oral communication skills. - Be able to work office-based in Warsaw Remuneration & other details What is offered We offer: •Full time permanent employment •Car allowance or company car •Work in the unique organization in Warsaw To Apply: Please contact Dariusz Sternlicht, Recruitment Consultant at DOCS on or email your up-to-date CV to: About DOCS: DOCS provides global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical trial industry. Key words: Clinical Research Associate, CRA, Monitor, on-site monitoring, Study Conduct, Regulatory, Pharmaceutical, CRO, Pharma, Contract Research Organisation, Biotech, Medical Device, Health, Biotechnology, Chemistry, Permanent, Warsaw, Poland

Reference: 671078627

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