US-MI-StLouis: Clinical Research Associate

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Date: 30-Dec-2008

Clinical Research Associate II

Seeks Clinical Research Associates. The successful candidate will perform clinical monitoring process in accordance with GCPs and SOPs to assess the safety and efficacy of investigational products. You will work on assigned project teams in the execution of clinical research programs designed to support Company’s effort to obtain New Drug Applications and Abbreviated New Drug Applications for various therapeutic entities. Responsible for efficient performance of assigned clinical research project tasks to ensure that project/program milestones and objectives are met. If you have experience reviewing protocols, designing and/or reviewing CRFs, developing annotated CRFs, preparing Patient Information Sheet (PIS) / Informed Consent (IC) forms, and preparing clinical management plan and associated study documents (for example, monitors' reference manual and study reference manual) apply today.

Bachelor’s degree required (RN, BSN, BS/MS or BA in Health or Biological Sciences preferred). Two to four years experience as a Clinical research associate in a pharmaceutical, biotechnology or CRO company is required. The successful candidate will have clinical monitoring and operations experience and understand the roles and interactions between the support functions in the clinical study operations process including safety, regulatory, biometrics, data management, and clinical supplies. Knowledge of and experience with FDA/GCP/ICH requirements for clinical trial conduct and clinical monitoring is required. This position will travel up to 60% of the time. You must be Microsoft proficient and possess excellent communication skills.

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BioTech FYI Center
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