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CRA

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

Madrid, Madrid Spain
Research & Development
12 Mar 2019
Annual Salary
Full-Time
Job Summary We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life. Roles & Responsibilities of the position Responsible for the support and management of study sites for Phase I clinical Oncology and Hematology studies according to SOP's, GCP regulations and protocol requirements. Identify, evaluate and recommend potential study sites for participation based on feasibility Perform pre-trial assessment visits and coordinate site initiation visits Assures that site personnel complete and document protocol-specific training Conducts on-going study visits and perform Monitoring visits on a routine basis Performs source documentation as required by SOP to ensure protocol/patient compliance Reports any site issues to Clinical Team Ensures that Trial Centre File (TCF) is current up to date Performs drug accountability and any re-labelling that may be required Responds to site questions and escalates as necessary for resolution Attends investigator meetings Participate in QA or FDA audits when necessary Job Requirements Education: BSN/BS/MS or BA required Experience: a minimum of two-three years independent monitoring experience in Phase I Studies TA: Oncology and Hematology Knowledge of Microsoft Office applications especially Excel English: Fluent spoken & written Good interpersonal skills demonstrated as proactive, enthusiastic, and independent thinker Ability to collaborate and build strong relationships with all functions involved in the trial Works and meets deadlines with some supervisión Remuneration & other details We offer a permanent contract, full time role office based in Madrid To apply please send your update English CV to About DOCS: DOCS clients include small, mid and large sized Pharmaceutical companies in addition to many leading Biotechnology, Medical Device companies and CROs. As a global partner, DOCS currently offers global resourcing solutions to our clients

Reference: 671078635