Clinical Research Associate

Title: Clinical Research Associate
Duration: 06 Months with possible extension
Location: Alameda, CA, 94502

Description:

Note: Travel Requirements-20-35% anywhere in USA, whenever needed.

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 of data, and completion of study summary. 3-5 Years Experience Level.


Must have "Clinical Research Monitoring" experience.
Will be performing study site visits ~ qualification visit, Introduction visit, interim monitoring visits and Close out visits.
Will be generating Monitor reports and tracking to get resolutions to any items that need attention.
Will Monitor compliance to ICH guidelines, study protocol GCP (good clinical practice), Federal regulations, and any other regulations.
Will monitor study documents including Trail Master Files.
Will perform review of clinical data study listing.
Will report to management and escalate any items needed.
Will account for devices during study.
Prefer medical device background but will accept Pharma


~ Top Skills: 1) Monitoring exp. 2) great attention to detail and good organizational skills 3) a PLUS is have exp. with EDC (electronic data capture) or Electronic Master Files
Employment Type: Contractor
Salary: $ 50.00 55.00 Per Hour