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Title: Clinical Research Associate II - North Carolina
Job listing published: 6/14/08
Location: North Carolina
Department: Clinical Operations
Contact: To apply for this position, please email your resume to Synteract Jobs.
Description
Based in our new Morrisvilee, North Carolina, office, you will perform the on-site monitoring of clinical studies. You will assist in the identification of potential clinical investigators and evaluate qualifications of investigators and site personnel; determine if facilities are adequate based upon protocol requirements; monitor Case Report Forms (CRFs) for trends in safety and ensure the timely reporting of adverse events and study progress; monitor ongoing clinical research by maintaining close communication with study investigators and by inspection of study site records to verify data validity and to ensure compliance with the protocols, federal regulations, SOPs and GCPs; motivate sites to complete study enrollment and follow-up visits within projected timelines; ensure stock of clinical supplies is sufficient to meet study needs; ensure availability of all final study documentation in anticipation of a Sponsor or FDA audit. Will travel more than 60 - 70% within the designated East Coast territory.
Bachelor's degree in a life science, B.S.N., Registered Nurse, or equivalent and a minimum of 2 - 4 years' relevant experience, to include 2 years monitoring experience. Certified Clinical Research Associate certificate desired, not required. Valid driver's license is required. Requires working knowledge of GCPs, ICH guidelines and FDA regulations. Must possess a professional demeanor. Must be able to work independently, to effectively manage multiple priorities, to effectively provide instruction and coaching to site personnel, and to identify, communicate and resolve issues identified. Must demonstrate teamwork and keen attention to detail.
