Clinical Research Associate in Alameda, CA

The Manager is looking for CRA's who have traveled to monitor and document clinical studies at various sites.

50% travel is required for this position. 10-15 visits onsite

work is allowed Up to 25%

• The candidates may be located in Alameda but will travel to sites around the US to monitor and document clinical studies at various client sites and the hours may not always be 8 to 5.
• The candidates need to be familiar with government regulations and have very good communication skills as they will be representing client when out at these sites.
• The Studies are expected to start in Feb/March time frame but would like to have the candidates trained prior to.
• The candidates may start earlier than January but that will be determined when selected
• Member of the clinical team responsible for conducting Phase I-IV single or multi center studies according to Federal Regulations and ICH guidelines.
• Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions.
• Responsible for writing basic study protocols, monitoring or overseeing monitoring of investigational sites to ensure protocol adherence
• Assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification o data, and completion of study summary
• 3-5 Years’ Experience Level.

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