Clinical Research Associate

Position: Clinical Research Specialist, Req# 18246-1 Location: Irvine, CA (100% onsite) Duration: 12+ months contract to hire Job Description :The main function of a clinical research specialist is to perform study start-up and conduct activities including ICF review that meet regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activities . Education and Experienc e:Bachelor's Degree or equivalent in a related fie ld2-4 years of experience requir edClinical background, familiar with clinical study process, monitoring, GCP and clinical study relevant regulation s.High compliance requirements and understanding that the rights and well-being of human subjects should be protected during a clinical stu dy Key Responsibiliti es:Perform study start-up and conduct activities including ICF review that meets regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activit iesIdentify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study pha sesIdentify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study pha sesConduct in-house and site (if applicable) reviews of associated documentation and participate in internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Edwards internal SOPs, and US and OUS regulati onsAssess current processes, identify opportunities and propose solutions to improve process efficiency within and across related functional ar easPartner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolut ion