Clinical Research Associate

hace 2 días

Zaragoza, España Indiana Biosciences Research Institute A tiempo completo

.About this roleClinical Research Associate (Madrid) - Regionalized position - Single sponsor - Onco/hematologyAbout 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 Responsibilities Monitor on-site and remotely clinical trials in accordance with TFS and/or client companyStandard Operating Procedures, FDA regulations, and GCP and ICH guidelines Review CRFs (paper or electronic) and subject source documentation for validity andaccuracy and generate queries to investigational sites/clients to resolve problem data Identify site problems/deficiencies and bring to the attention of management through tripreporting, memos, and verbal communication with Project Manager or Lead CRA Initiates corrective action to resolve issues as directed by supervisor Contribute 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 Manager Participate in contract handling and negotiation directed by Lead CRA/Project Manager Set up ISF and SMF (or cooperate with CTA) and distribute to the investigational sites. In cooperation with study team, responsible for SMF maintenance Order, ship, and reconcile clinical investigative supplies for study sites, if applicable Order, ship and coordination of study supplies at site May prepare and submit status reports as directed by Lead CRA/PM Review and support site staff to maintain SMF Review Informed Consent documents for essential elements and protocol specifics Update CTMS system with site and study information May audit data in tables and text of clinical summaries May assist in the preparation of study documentation such as CRF Completion Guidelines,patient diaries, study participation cards by reviewing for accuracy and completeness Prepare check requisitions for sponsor Project Manager approval, when applicableQualifications: Bachelor's Degree, preferably in life science or nursing; or equivalent Minimum 2-3 years of relevant clinical experience Able to work in a fast paced environment with changing priorities Understand basic medical terminology and science associated with the assigned drugs andtherapeutic areas Possess the understanding of Good Clinical Practice regulations, ICH guidelines Ability to work independently as well as in a team matrix organization Excellent written and verbal communication skills

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