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Job #02690

About our client Our client is a rapidly growing global CRO headquartered on the East Coast. The company has managed close to 150 protocols, boasts a deep network of over 3000 sites and has developed unparalleled expertise in cardiology and device studies. With strong financials, an experienced management team and loyal customer base, this is a strong opportunity for someone that wants to put their drive and initiative to work! Position Location Clinical Research Associate (Home-Based) USA Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop a detailed working knowledge of all assigned protocols 2) Manage sites according to project-specific monitoring guidelines and instructions from the Lead CRA 3) Schedule monitoring visits with all sites for the project (as required and outlined by the Lead CRA) while working within budgetary guidelines 4) Communicate with site personnel, in-house Project Team and the sponsors as well as inform them of the expectations and results from the monitoring visits 5) Write visit reports in the time frame required by the project 6) Review available in-house data relating to recruitment and CRF status as well as preliminary data from fax data systems or remote data entry systems, prior to visiting the site for each monitoring visit 7) Ensure that study recruitment goals and completion timelines are met as well as make suggestions to improve enrollment (if necessary) 8) Review source documents and Case Report Forms (CRFs) for each subject, as per country-specific regulations, ICH-GCP guidelines and company SOPs to ensure timely, accurate and quality data retrieval 9) Maintain internal and external study files along with ensuring that regulatory and other documents are complete, accurate and in accordance with all requirements 10) Support administrative duties necessary for in-house, study site and data management operations, under the supervision of Clinical Team 11) Assist the Project Manager in study management 12) Collect completed and monitored CRFs 13) Forward collected CRFs to Document Control and document them 14) Facilitate the timely resolution of queries (either in-house or at the site) and track any outstanding queries to ensure that process is completed and timelines are met 15) Maintain inventory, retrieve clinical supplies and monitor disposition records 16) Participate in training and mentoring new CRAs (as requested) 17) Attend pertinent classes, seminars and other training sessions to maintain a high level of expertise in monitoring and cardiovascular interventions and treatments 18) Complete time and expense reports, 19) Perform other administrative activities (as required) Requirements 1) RN/BS degree in Biological Sciences/related field or equivalent combination of education and experience 2) 4+ years of CRA experience in monitoring clinical trials from qualification to closeout 3) Experience in monitoring renal/hemodyalis or device trials 4) Superb interpersonal, communication and problem-solving skills 5) In-depth knowledge and understanding of FDA regulations and GCPs