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The Palo Alto Medical Foundation (PAMF) is a notforprofit, communitybased multispecialty group practice of medicine. PAMF patients are cared for by the more ...
For your reference, we have included the original job posting below.
Clinical Research Associate (CRA)
Job Number:
26878231
Company Name:
Aerotek Scientific
Job Location:
Sunnyvale, CA US
Job Category:
Research
Clinical Research Associate (CRA)
DetailsThe Senior Clinical Research Associate, Clinical Operations will coordinate the activities associated with the evaluation, initiation, management, and close-out of clinical trials within the Clinical Development department. The Senior CRA role provides an outstanding opportunity to work in a matrix environment and collaborate with colleagues in clinical data management, biostatistics, regulatory, safety, and early development. RESPONSIBILITIES:Clinical Study Management Identify, select, and monitor investigational sites for clinical studies Ensure studies are carried out according to study protocol, SOPs, and ICH/GCP regulations Track progress of study including patient enrollment, monitoring visits Investigate queries, monitor discrepancies Manage the site conduct, and the investigational product accountability and reconciliation process Negotiate and manage the budget and payments for investigative sites and contract organizations Design and administer case report forms Write or contribute to preparation of clinical protocols, amendments, consent forms, study guides, CRFs, and any other clinical research related document Develop queries for data analysis Review of data listings and summary tables, including query generation Oversee performance of CROs and field CRAs to ensure compliance with study protocol Co-monitor sites with field CRAs Train CRAs on protocols and practices consistent with GCP standards Assist in identification and hiring of appropriate CROs and study vendors Generation and/or review of relevant sections of clinical study reports, IND annual reports, and Investigator Brochures May require up to 40% travel Category: Medical Sciences
