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Senior Clinical Research Associate Resume - PDF

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					                    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: hr@avigen.com, fax: (510) 748-7371. EOE -
Principals Only – No Phone Calls.

				
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