CRA Madrid - Single sponsor - Recognized Biotech CompanyAbout this roleTFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions.As part of our SRS/FSP team, you will be dedicated to one sponsor, a global biotech company that is an industry leader in onco-hematology.Key ResponsibilitiesMonitor on-site and remotely clinical trials in accordance with TFS and/or client companyStandard Operating Procedures, FDA regulations, and GCP and ICH guidelinesReview CRFs (paper or electronic) and subject source documentation for validity andaccuracy and generate queries to investigational sites/clients to resolve problem dataIdentify site problems/deficiencies and bring to the attention of management through tripreporting, memos, and verbal communication with Project Manager or Lead CRAInitiates corrective action to resolve issues as directed by supervisorContribute to the completion of the application to Ethics Committee/IRB, prepare necessarydocumentation enclosed to the application according to local requirements in cooperationwith CTA and directed by Lead CRA/Project ManagerParticipate in contract handling and negotiation directed by Lead CRA/Project ManagerSet up ISF and SMF (or cooperate with CTA) and distribute to the investigational sites.In cooperation with study team, responsible for SMF maintenanceOrder, ship, and reconcile clinical investigative supplies for study sites, if applicableOrder, ship and coordination of study supplies at siteMay prepare and submit status reports as directed by Lead CRA/PMReview and support site staff to maintain SMFReview Informed Consent documents for essential elements and protocol specificsUpdate CTMS system with site and study informationMay audit data in tables and text of clinical summariesMay assist in the preparation of study documentation such as CRF Completion Guidelines,patient diaries, study participation cards by reviewing for accuracy and completenessPrepare check requisitions for sponsor Project Manager approval, when applicableQualifications:Bachelor's Degree, preferably in life science or nursing; or equivalentMinimum 1-2 years of relevant clinical experienceAble to work in a fast paced environment with changing prioritiesUnderstand basic medical terminology and science associated with the assigned drugs andtherapeutic areasPossess the understanding of Good Clinical Practice regulations, ICH guidelinesAbility to work independently as well as in a team matrix organizationExcellent written and verbal communication skills.Excellent organizational skillsAbility and willingness to travel up to 60-70%What We OfferWe provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patientsA Bit More About UsOur journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.Social BenefitsHealth Insurance/Lunch Allowance/Flexible remuneration/Overtime compensation/Summer working hours/FlexibilityTogether we make a difference.
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