• Serve as the primary point of contact to study sites during start-up • Work in a team setting managing multiple clinical study protocols • Responsible for all regulatory tasks pertaining to assigned studies • Reviews Sample and Site Informed Consent forms for compliance with the rules and regulations set forth by the FDA • Reviewing and approving site activation packages • Ensure that all assigned start up activities are on track and support study deliverables • Maintaining accurate, complete and current information in the appropriate databases • Organizes regulatory information and tracks study documents • Collecting and reviewing, of regulatory documents for completeness and compliance to the rules and regulations set forth by the FDA and the study sponsor • Filing in eTMF system and accurate Trial Master File Maintenance • Maintains Consistent site follow-up and ensure documents required are collected in a timely manner • Ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement • Researches regulatory issues and provides guidance and advice to colleagues • Participates in various start-up and Sponsor Kick-Off meetings • Escalate study issues appropriately and in a timely manner • Performs other duties as assigned