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Job #02890

About our client Our client is a diagnostics company based in California. They offer products and services used by the industry to assist with the diagnosis, treatment and management of infectious diseases. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Clinical Research Associate Cypress, Southern California Salary Highly competitive package, commensurate with experience Responsibilities 1) Coordinate clinical trial process for new diagnostic products 2) Write of clinical trial protocols 3) Establish capabilities required for the clinical trial sites to complete the protocols 4) Identify sites having proper clinical trial capabilities 5) Manage the clinical trial contract process and clinical trial sites for compliance 6) Train clinical trial sites and internal departments 7) Coordinate the logistics of sample and data transfer as well as cost accounting of the clinical trial process to be performed 8) Manage post-clinical trial activities (coordinating cross-functional teams to launch a new product or device) 9) Ensure publications and white papers are available 10) Assist in the pre-market positioning of the new product 11) Oversee the clinical trial sites (global) and travel periodically (as required) 12) Maintain broad understanding of clinical research and knowledge of US CFR, ICH, EU, Canadian and GCP guidelines 13) Work with staff to identify potential external sites for the evaluation of new IVDs and performance of clinical trials 14) Perform detailed investigations, including site visits, to evaluate the technical capability of potential external collaborators 15) Participate in the identification of collaborators that can provide critical clinical specimens for R&D feasibility and verification studies as well as for manufacturing validation studies 16) Initiate contract negotiations with external collaborators and present to the appropriate company personnel for final signature 17) Participate in the development of clinical trial protocols (evaluation of the individual site’s technical and logistical capabilities to perform the protocols) 18) Review (periodically) the sites for contract compliance during the clinical trial process 19) Coordinate and manage the clinical specimen acquisition process 20) Liaise with external collaborators for the exchange of information regarding contracts, IRB/HIPPA information, clinical trial instructions, technical data and reports 21) Coordinate any training required at external collaboration sites, including on-site training 22) Monitor the performance of clinical trial sites by reviewing procedures, personnel and data generated at the sites, including periodic visits to all clinical trial sites 23) Serve as the coordinator of cross-functional departments and teams (e.g. R&D, manufacturing, RA, etc.) to bring products through the regulatory process to launch 24) Oversee and work closely with the clinical trial sites to ensure that clinical trial data is published in peer-reviewed journals or other appropriate platforms 25) Ensure accuracy of results while meeting timelines 26) Assist in developing economical models for the proper positioning of new products for the market 27) Identify speakers, venues and other resources for the pre-market positioning of new products 28) Set-up and maintain a cost accounting and management system for external test and clinical trial sites 29) Research technical questions through review of periodicals, interaction with in-house personnel, the Internet, etc. 30) Perform assigned tasks in accordance with applicable safety regulations and instructions 31) Correct unsafe work habits and/or inform the Safety Team or a Supervisor of any practice that may harm the safety and health of the employees 32) Cooperate in all safety or health-related programs and assist in solving safety and health problems 33) Ensure that violation of safety directives and procedures are handled in accordance with the established company disciplinary process 34) Perform other duties as assigned Requirements 1) BS in Biology or Microbiology 2) Minimum 5 years of experience in IVD, or in laboratory medicine or medical technology 3) Experience in laboratory platforms similar to those that will be used in future clinical trials 4) Experience in managing CROs 5) Knowledge of and experience in all of the company’s products in-development and slated for clinical trials 6) Experience in interacting and communicating with external collaborators and clients 7) Expertise in the design of PMA IVD clinical trial and NAT clinical trials 8) Superb time management and people skills 9) Ability to maintain documentation and meet specified quality standards 10) Proficiency in MS Office applications 11) Excellent communication and project management skills