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Regional CRA - North East Opening - Permanent
ion - Can be located home based anywhere in the North East from DC on up next to a major airport. Travel will be throughout the North East region Minimum REQUIREMENTS: Experience monitoring or coordinating cardiology clinical trails At least two years or more monitoring clinical trials as a CRA - please do not apply unless you have clinical trial monitoring experience as a CRA Bachelor’s degree in life sciences or related field or certification in a related allied health profession from an appropriately accredited institution. Nursing degree (RN) or other similar medical training preferred. Position will require 75% travel. Candidates must have strong leadership ability, exceptional communication and interpersonal skills, ability to work in a dynamic environment, multi-task and prioritize work. Two to five years experience in a scientific discipline required, preferably in clinical trial setting Prior experience in clinical trial monitoring of study coordination preferred Knowledge of FDA regulations on good clinical practices (GCP) Working knowledge of International Conference on Harmonization (ICH)-GCP guidelines for clinical trials preferred Demonstrated understanding of medical terminology preferred Job Description: Depending on level, the Clinical Research Associate will: Participate in and/or develop, coordinate and execute all aspects of clinical trial monitoring, including: Participate in site evaluation and selection Participate in study initiation and training Manage and conduct monitoring visits at clinical trial sites to ensure compliance with the study protocol Monitor site adherence to good clinical practices (GCPs) and FDA regulations Develop and/or implement methods for oversight/tracking of patient visits in order to facilitate plans for monitoring travel and data collection Review data/case report forms to source documents and assist in resolution of data queries Participate in various aspects of clinical study development including Protocol review Design and development of case report forms writing and assembling study/CRF instruction manuals and study procedure instruction guides SOP creation and revision
Coachella, California
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