The Clinical Research Associate (CRA) conducts site monitoring responsibilities for Clinical trials, according to Covance Standard Operating Procedures, ICH guidelines and GCP, including Pre-study, Site Initiation, Routine Monitoring, and Close-out Visits.
This person will primarily be responsible for carrying out computational efforts related to developing the process modeling capability for SMPG in order to enable fast-entry into human and the definition of market-image formulation/process.
The successful candidate will work both independently and as part of a team on design and optimization of viral vectors and host cell lines with the goal of improving the production and performance of viral vectors.
The successful candidate will work independently within a diverse collaborative group and will combine biochemical, cell biological and in vivo experimental approaches to understand the functional immunological processes related to autoimmunity.
Serve as a scientific and technical expert on project teams in the areas of transfusion medicine, hematology, and clinical trials, by contributing ideas and strategies, developing and executing plans, and reporting activities and results.
Strong ability to manage multiple tasks concurrently and in a timely manner, including large, complex projects. Excellent analytical skills, high level of statistics with the ability to identify and predict trends and anomalies.
This role will involve working in a collaborative team environment as part of the comprehensive safety assessment of Genentech therapeutics by providing discovery and investigative toxicology support to early stage small molecule research programs.
The ideal candidate will have significant experience in molecular and cellular biology using both in vitro and in vivo model systems, and possess a deep mechanistic understanding of the cellular pathways that contribute to diseases of the nervous system (e.g. neurodegenerative diseases).
Provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients lives.