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| Empresa: |
Sangamo BioSciences, Inc. |
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| Título del Empleo: |
Clinical Research Associate III |
| Categoría de Trabajo: |
Biotech |
| Localización del Empleo: |
Richmond - CA California - Estados Unidos |
| Número de Referencia de Empleo: |
CRA-III |
| Descipción del Empleo: |
Sangamo Biosciences, INC. JOB Description
Clinical Research Associate Iii
Sangamo BioSciences, Inc. (Nasdaq: SGMO) is the world’s leading developer of customized DNA-binding proteins for targeted gene regulation and genome engineering. We are applying this technology in diverse therapeutic areas including cardiovascular disease, diabetic neuropathy, neuropathic pain and HIV / AIDS. The company’s most advanced therapeutic compound, a designed zinc finger protein transcription factor that activates the VEGF-A gene, is in phase II testing for treatment of diabetic neuropathy. We also have active programs in crop engineering, the development of cell lines for biologics production, and the construction of animal models of human disease.
Essential Functions
Essential functions include, but are not limited to the following:
Assist in the design, planning and implementation of clinical research projects
Manage the development of protocols, Investigator Brochures, case report forms, informed consents, study manuals and study budgets
Negotiate and finalize site contracts and budgets, manage and calculate site payments
Perform site visits including site qualification, initiation, monitoring and close-out visits; co-monitor with regional monitors and review monitoring reports
Ensure adherence to the protocol providing for accurate data collection, documenting drug accountability and compliance with federal regulations
Represent Sangamo BioSciences in a professional manner; establish and maintain good relationships with investigators and study site personnel
Maintain frequent site contact; prepare and track required documentation and manage study supplies at clinical sites
Oversee and track project progress at assigned sites (patient status, safety/adverse events, CRF completion, payments, study drug supply, regulatory documents).
Review data listings on an ongoing basis
Assist in planning Investigator Meetings
Assist in preparing interim study analyses, annual reports, and clinical study reports
Manage external vendors, develop study specifications, and finalize vendor contracts; vendors may include and are not limited to Contract Research Organizations (CROs), central laboratories, interactive voice response service for randomization (IVRS)
Requirements
4 to 5 years of Pharmaceutical industry experience including direct site management
BA/BS degree in nursing, pharmacy, life sciences or health-related discipline
Thorough knowledge of GCP, ICH and FDA regulations
Strong organizational skills, detail oriented, and able to multi-task and work effectively in a fast-paced environment
Self-motivated, assertive and able to function independently or as part of a team
Strong written and verbal communication; strong interpersonal skills
Ability to travel 30-40%
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| Habilidades: |
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| Requerimientos de Idioma: |
Inglés-AvanzadoFrancés-IntermedioAlemán-IntermedioEspañol-Bueno
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| Tipo de Empleo: |
Tiempo Completo
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| Sueldo: |
83000 USD
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| Día de envío: |
13 jun 2008 |
| Nivel de Estudio: |
Licenciatura
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| Experiencia (Años): |
3 o 5 años |
| Empleo disponible también en: |
Point Richmond |
| Empresa: |
Sangamo BioSciences, Inc. |
| Nombre de Contacto: |
Sangamo BioSciences, Inc. |
| Método de Preferencia del contacto: |
E-mail vía Apply Online Box |
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