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Job #03602

About our client Our client is a leading medical device company that is focused on the development and commercialization of cutting-edge oncology therapeutics. The company has an established business of marketed products, an experienced management team and financial support from some of the strongest venture capital firms in the industry to fund ongoing programs. This is a strong opportunity for someone that wants to put their drive and initiative to work! Position Location Clinical Research Associate Minnesota Salary Highly competitive package, commensurate with experience Responsibilities 1) Ensure clinical trial compliance with federal regulations, GCPs, ICH guidelines and company SOPs 2) Assist clinical management with developing, negotiating and executing site contract, budget and payment plan, with final approval from them 3) Serve as key site management team member to internal and external partners 4) Provide on-call help for sites, as well as on-going site training 5) Participate in site qualification and initiation process including scheduling monitoring activities with site personnel 6) Assist clinical management with development, approval and distribution of study-related documents including CRFs, study protocols, amendments, monitoring plan, study manuals and other study tools to investigational sites and review committees 7) Oversee subject screening and enrollment at assigned clinical sites 8) Manage budget and payments for investigative sites and contract organizations 9) Manage the development and maintenance of clinical trial documents, processes and systems according to goals and budget 10) Manage distribution, collection and tracking of regulatory documentation to ensure compliance at both the sites 11) Sponsor central file and for audit readiness 12) Assist in planning, preparing and distributing materials for investigator and coordinator meetings and for study-related training 13) Track and report progress of studies including patient enrollment/screening, data collection, adverse event documentation and FAQs 14) Assist in query writing and resolution process, as required 15) Identify and gather missing or incomplete data from the investigational sites 16) Write or contribute to preparation of SOPs, consent forms, study guides, CRFs and any other clinical research-related documents 17) Assist with the development and/or maintenance of clinical infrastructure such as the drafting or reviewing SOPs and work instructions Requirements 1) Bachelor’s degree in a scientific or healthcare related discipline 2) Minimum 3+ years of experience as a CRA and 2 years of field monitoring experience 3) Experience in working on multiple oncology clinical trials 4) In-depth knowledge of FDA regulations, ICH and GCPs 5) Excellent organizational and communication (written and oral) skills 6) Willingness to travel (up to 75%)