Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies. In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct/metrics (enrollment, GCP practices, handling of safety issues, etc.)
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.
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.
The research will focus on implementing quantitative approaches and cutting edge instrumentation to probe post-translational signaling networks, with an emphasis on the ubiquitin system, cancer signaling pathways and cell death regulation.
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.
Successful candidates will have most of the following attributes: work independently in a collaborative team-oriented setting, be process oriented, and must have demonstrated strong analytical, organizational, leadership, and communication skills.
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 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).
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.