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Job #02833

About our client Our client is a rapidly growing medical device company, headquartered in California that is focused on the development and manufacturing of neuromodulation products that help patients suffering from CNS disorders. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Clinical Research Associate Valencia, South California Salary Highly competitive package, commensurate with experience Responsibilities 1) Work with RA Team members and outside investigators (directly), to participate in study development and execution 2) Coordinate activities and clinical proposals of multiple outside investigators 3) Develop and implement clinical protocols 4) Analyze, evaluate and report results of clinical studies 5) Ensure that the collection quality of data from patient charts, medical records, interviews, questionnaires, diagnostic tests, etc. are complete and documented appropriately 6) Design and/or review CRFs, Patient Information Sheet (PIS) and ICFs 7) Develop the Clinical Management Plan and associated study documents such as monitors' reference manual and the study reference manual 8) Develop/maintain monitoring strategy and activities, including identifying non-conformity with company procedures and SOPs 9) Recommend/Implement corrective and/or preventative actions 10) Monitor clinical study sites and subject progress 11) Review site visit reports 12) Ensure that reports are completed and distributed as per applicable SOPs and international/national regulatory requirements, project scope of work as well as approved budget and timelines 13) Develop data management plans and Quality Management (QM) plans that will deliver accurate, timely, consistent and high-quality clinical data 14) Develop monitoring plans and CRF guidelines 15) Assist with SAE information collection and routing 16) Handle site management and performance (including documentation) of on-site monitoring activities for multiple investigational sites 17) Ensure that all site activities adhere to designated project assignments and applicable company SOPs, GCPs and applicable international/national regulatory requirements 18) Perform other essential tasks as assigned Requirements 1) BA/BS or MS in Life Sciences, Engineering, or any healthcare-related discipline 2) 3 years of experience in the medical device industry (manufacturing environment preferred) 3) Expertise in medical writing and clinical study design 4) Knowledge of clinical research procedures and FDA guidelines regarding the conduct of clinical research 5) Excellent organizational skills with keen attention to detail 6) Superb analytical and interpersonal skills 7) Excellent communication and writing skills 8) Good knowledge of MS Office, Internet, databases, etc. 9) Ability to work with minimal supervision in a busy environment 10) Ability to react to change productively