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Job #02803

About our client Our client is a rapidly growing medical device company headquartered in California that is focused on the development and manufacturing of biological implants that are used during surgery to reinforce soft tissues. The company has marketed products, an experienced management team, and an empowering corporate culture that is focused on the professional development of its employees, this is a great opportunity for the right candidate! Position Location Senior Clinical Research Associate/Clinical Project Manager Irvine, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop, execute and manage clinical studies, including writing of study protocol, informed consent, case report forms, study reports and summaries as well as other study-related documents 2) Evaluate and recommend selection of investigators/study sites independently 3) Participate in identifying potential sites 4) Train investigators, coordinator and other trial staff in data collection methods independently 5) Ensure collection of patient data that is accurate, complete and conforms to project data standards and protocol requirements 6) Monitor and close-out clinical studies, ensuring adherence to protocol, accurate data collection on CRFs via comprehensive source document verification and device accountability 7) Ensure the collection and updating of all essential documents are as defined by FDA regulations, the client, SOPs and general industry standards 8) Develop solutions for logistical and operational issues that arise during trials execution and communicate these in a timely fashion to investigators, Coordinator and staff 9) Identify and prepare written reports for product complaints, serious or unexpected adverse events 10) Attend relevant scientific and/or medical meetings 11) Maintain a high level of professional expertise through familiarity with clinical literature 12) Participate in Project Team meetings 13) Work with clinical data analysts and biostatisticians to maintain, analyze and report outcomes data 14) Prepare accurate and timely study reports and disseminate outcome results to clinical investigators, internal clinical personnel and external groups 15) Support company goals and objectives, policies and procedures, Good Clinical Practices as well as FDA and other notifying bodies’ regulations Requirements 1) R.N. or Bachelor's degree in a healthcare-related field 2) Minimum 4 years of clinical experience, including CRA and/or clinical project management experience 3) Ability to work independently and with teams 4) Multi-tasking abilities 5) Detail-oriented and organized 6) Demonstrate excellent interpersonal and customer-relations skills 7) Self-starting abilities with work flexibility 8) Good computer literacy 9) Superb written and verbal communication skills