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Clinical Project Associate - II
Ref No.: 18-12496
Location: Foster City, California
Clinical Project Associate II
Foster City
Duration - 12 months

Tracking and preparing study-specific information utilizing databases, spreadsheets, and other tools. Provide input and assist with harmonization of Clinical Operations databases and tracking tools. Assist in the maintaining clinical information and training of Clinical Operations personnel in the clinical trials database . Processes re-supply drug shipments. Order and maintain inventory of clinical supplies. Order and ships case report forms. Assists with development of documents for site binders. Assembles and coordinates distribution of site binders. Serves as CRA back up providing verbal and written communication with study personnel. Under close supervision reviews and participates in the quality assurance of data or documents. Arranges meeting logistics. Drafts meeting agendas and assists in preparing meeting minutes. The position interacts with other departments, as directed, to complete assigned tasks. May assist with monitoring visits under the direct supervision of senior staff. Travel may be required. Assist with the planning and facilitation of investigator meeting and, when applicable, provide on location support during the meetings.

Hiring manager notes:
Candidate will be involved with Phase II/III studies, 4 in total currently over 430 sites study is for inflammation but open to other Therapeutic Areas Studies in start up but transitioning to maintenance, milestones will occur next year CRO experience Veeva TMF + TMF
2-3 years experience
managing meeting minutes and agendas
following up with stakeholders
tracking protocol errors/deviation globally Will be mentored by a former CPA contractor that was converted to FTE

All the culture, values mentioned during the Supplier Forum engaged motivated willing and not scared to ask questions doing things right the first time pro-active