Site Activation Specialist (SSU/RSU)(Evergreen)
Site Activation Specialist (SSU/RSU)(Evergreen)
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Job Description
Job Overview
Under moderate supervision executes the feasibility site identificationregulatory start-up and maintenance activities in accordance withregulations 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 moderate oversight and supervision perform tasks at a country/region level associated with site activation 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
With moderate oversight and supervision serve 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.
Qualifications
Bachelors Degree Life sciences or a related field Req And
Other 1 - 3 years clinical research or other relevant experience; or equivalent combination of education training and experience. Req
With 3 years experience in a healthcare environment or equivalent combination of education training and experience.
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
Required Experience:
Unclear Seniority
Employment Type
Full-Time
