Site Activation Specialist

Qualifications• Client Dedicated• Regulatory Start Up/CRA/SC 등 유관 업무 경력자• IRB submission, Budget/Contract negotiation, Essential document package preparation, Site Activation and etc.• 경력에 따라 junior coaching 수행• Good English communication skill is required

Job OverviewUnder moderate supervision, executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements  at the regional, or country level.Prepares and manages site documentation; reviews and negotiates site  documents and contracts with sites and sponsors; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of appropriate documents for sites; ensures contracts are fully executed; and establishes project timelines.  With moderate oversight and supervision, perform tasks at a country/region level associated with site activation activities in accordance with  applicable local and/or internationalregulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Essential Functions• With moderate oversight and supervision, werve a Single Point of Contact (SPOC) to perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the  Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review documents for completeness, consistency and accuracy, under guidance of senior staff.• Prepare site documents, reviewing for completeness and accuracy.• Inform team members of completion of regulatory contractual. and other documents for individual sites.• Distribute completed documents to sites and internal project team members.• Update and maintain internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.• Review, track and follow up the progress, the approval and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents. Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.