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Job #03199

About our client Our client is a global CRO with operations in over 40 countries. It has an experienced CEO and management team that is committed to the highest standards of integrity as well as to improve the lives of patients and their families. This is a strong opportunity for someone that wants to put their drive and initiative to work. Position Location Clinical Research Associate New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Monitor India operations and report progress to Management 2) Liaise and participate in managing study-specific vendors (e.g. CRO, central laboratory, etc.) 3) Provide inputs on departmental decisions related to study processes and procedures 4) Participate in routine clinical data reviewing (as directed) 5) Contribute to study protocol designing, protocol reviewing and protocol finalization 6) Conduct site monitoring visits 7) Ensure compliance with quality standards, data management SOPs and guidelines as well as reporting activities 8) Identify/evaluate issues related to the project and implement resolutions 9) Participate in designing/developing CRFs, informed consent templates as well as study-related processes and manuals 10) Provide updates to other company departments 11) Manage/monitor all aspects of clinical study implementation as per FDA regulations, ICH/GCP guidelines and company SOPs 12) Handle on-site and in-house monitoring duties (as required by local and federal regulations) Requirements 1) BA/BS with 2 – 3 years of experience as a CRA in the pharmaceutical industry 2) CRA certification a plus 3) Knowledge and understanding of current regulatory issues related to Phase I –IV clinical research 4) Proven ability to monitor a team based at an overseas location 5) Excellent time management, communication and organizational skills along with proficiency in Microsoft Word, excel and PowerPoint 6) Ability to multi-task, prioritize critical path activities above other study-related activities and work independently as well as in a team 7) Willingness to travel internationally (25% to 30%)