Hi-469 - Senior Regulatory & Start Up Coordinator

Job Overview
Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements, and contractual/budgetary guidelines. May also include maintenance activities.
Essential Functions Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables, and project timelines.Perform start-up and site activation activities according to applicable regulations, SOPs, and work instructions. Distribute completed documents to sites and internal project team members.Prepare site regulatory documents, reviewing for completeness and accuracy.Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information.Review and provide feedback to management on site performance metrics.Review, establish, and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plans as needed.Inform team members of completion of regulatory and contractual documents for individual sites.Review, track, and follow up the progress, approval, and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.Provide local expertise to SAMs and project team during initial and ongoing project timeline planning.Perform quality control of documents provided by sites.May have direct contact with sponsors on specific initiatives.
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