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Job #02794

About our client Our client is a leading global healthcare supplier that develops, manufactures and distributes over-the-counter (OTC) and prescription pharmaceuticals, nutritional products, active pharmaceutical ingredients (API) and consumer products. The company is the world's largest manufacturer of OTC pharmaceutical products for the store brand market. The company's primary markets and locations of manufacturing facilities are the United States, Israel, Mexico and the United Kingdom. Position Location Senior Clinical Research Associate Bronx, New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Monitor clinical investigator sites and other service providers 2) Generate and review monitoring reports and clinical study reports 3) Assess scientific reports and clinical data 4) Follow-up on corrective and preventive action to ensure continuing data integrity and operational compliance 5) Conduct external audits/monitoring visits of clinical investigator sites, CROs and partnering companies (both domestically and internationally) 6) Generate and review site-monitoring reports 7) Review and provide feedback on clinical study reports 8) Assist the Director and project managers in tracking internal SOPs, training and compliance documents as per SOPs and departmental policies 9) Author and revise SOPs 10) Support generation of submission reports to the FDA 11) Assist in the distribution of IND safety letters 12) Work closely with Pharmacovigilance and Regulatory Groups to monitor AEs/SAEs and report to the FDA 13) Maintain pharmacovigilance data in the database Requirements 1) Bachelor’s degree in Physical/Life Sciences, Nursing, Pharmacy or equivalent experience 2) 3 – 5 years of pharmaceutical clinical research and/or QA monitoring experience 3) Knowledge of current and pending FDA regulations, 21CFR and GCP and ICH guidelines 4) Focus on areas that need improvement in a manner that is constructive and non-confrontational 5) Willingness to travel (domestic and international) – up to 50%