CLINICAL RESEARCH ASSOCIATE Avigen, Inc., located in Alameda, CA is committed to providing physicians and their patients with innovative therapeutics for the treatment of neurological conditions. Avigen's strength lies in its innovative employees, rigorous science and a focused strategy on treatments for serious and life-threatening neurological disorders. Currently, we have an exciting opportunity for an experienced CRA to facilitate and manage the conduct, monitoring, and data management of Avigen clinical trials, and assure compliance in accordance with the Good Clinical Practices Regulations. The candidate must have knowledge and understanding of the Code of Federal Regulations (CFR) sections relating to the obligations of Sponsors and Investigators of Clinical Trials, Good Clinical Practices (GCPs), Protection of Human Subjects, Institutional Review Boards (IRB), Safety Reporting and the Department of Health, Education and Welfare (DHEW) and all applicable guidelines including ICH. This position requires a Bachelor’s degree in biologic sciences, Nursing, or RN with 3-5 years of experience as a CRA in the pharmaceutical industry. This position will be the primary interface with the study sites, and contract monitors. Will interact with study coordinators and investigators to organize/facilitate project timelines, ensure compliance with study protocols and achieve clinical objectives, ensure receipt, completeness and accuracy of clinical documents, establish study procedures and guidelines/conventions, assist in the development of protocols and case report forms in conjunction with the Clinical Affairs supervisor and others as appropriate (biostatistician, CRO), monitor study sites for compliance with GCPs and train site personnel if necessary, prepare accurate monitoring reports, identify and prioritize issues, ensure adequate follow-up, responsible for the prompt narrative completion, reporting and tracking of SAEs, coordinate the development of Investigator Brochures, final reports, clinical portions of INDs, interim and annual reports and BLAs, establish clinical project plans and be responsible for overall clinical project management, coordinate drug supply with production, maintain a high level of professional expertise through familiarity with clinical literature. Candidate must be able to effectively communicate study progress to the Clinical Affairs supervisor, project team and senior management. Must also have strong interpersonal, communication, problem solving and leadership skills, proven ability to effectively handle multiple issues simultaneously, attention to detail, strong organization skills, the ability to work with minimal supervision, display good judgment, risk analysis, and decision-making in the practical implementation of studies. To apply, email/send/fax resume to: Avigen, Inc., Human Resources, 1301 Harbor Bay Parkway, Alameda, CA 94502; e-mail: email@example.com, fax: (510) 748-7371. EOE - Principals Only – No Phone Calls.
Pages to are hidden for
"Senior Clinical Research Associate Resume - PDF"Please download to view full document