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Clinical Research Coordinator

039;s client is seeking a Clinical Research Coordinator for their New York territory. The CRC is responsible for supporting clinical research staff and managing new and ongoing clinical research activities. The position includes assisting clinical investigators and research staff to drive projects forward by interacting closely with external clinical research organizations and sponsors. The CRC will adhere to GCP, ICH, and FDA guidelines in the conduct of all study related activities. Duties and Responsibilities: Provide study coordination for assigned trials as directed by the Clinical Research Manager; including data coordination and quality control of research data. Provide back-up and support for all areas of clinical research. Complete regulatory paperwork for IRB submissions, annual reviews and study close-out. Ensure that all Serious Adverse Events (SAEs) are reported in a timely fashion to IRB and sponsor. Create and update Regulatory Binder for each assigned study. Interact/liaise with study sponsors and investigators in role of study representative. Conduct eligibility screening interviews over the phone and/or in person... Communicate clinical trial status to management and staff through meetings and tracking system; maintain related records. Create and update paper and electronic study patient records. Must understand how to create complete source documents May be asked to attend Investigator Meetings for new trials as assigned. Perform other duties as assigned. Knowledge, Skills and Abilities: Preparation of all study documentation such as protocols, amendments, case report forms, SAE reports and study reports are an integral part of this job Must understand GCP/ICH guidelines Specimen processing and shipping Applicants must meet the following requirements: Must have knowledge of managing a clinical research site Must have at least 4 years as a CRC Bilingual Spanish is a plus not required Must be able to draw blood Experience completing EKGs Experience reporting adverse events Experience completing regulatory packets Experience creating and completing source documents Ability to travel between Manhattan and Brooklyn sites Must be authorized to work in the United States.

Miramar, Florida