Study Start Up Associate I

hace 3 semanas

Madrid, España Icon Strategic Solutions A tiempo completo

.As a Study Start Up Associate, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.The SSUA is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and client standards. Responsibility within a country and may span over more than 1 country depending on the geographical region and business needs.What you will be doing:Clinical Trial Site ActivationInitiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation.Register investigator sites and client stakeholders in client registries and systems as required. Update and regularly maintain the registry with accuracy and have it inspection ready.Work directly and interact with investigator sites to confirm readiness for site start-up by reviewing study site profile ready in SIP or reviewing/completing critical information Sheet inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, Site contracts contacts, clinical supply shipment information, payment information, IRB submission and status.Take the lead to resolve issues or concerns and timely escalation of Site issues where applicable.Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines.Manage and coordinate with other supporting roles to ensure timely site activation and operational activities.Support the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study (where applicable) and other committees as per country requirements.Coordinate the timely communication, documentation and responses between Client and Central Ethics committee to bring clinical study to approval (country dependent).Support investigators sites with local IRB workflow from preparation, submission through approval.Assist with preparation, handling and distribution of non-Clinical Trial Supplies and maintenance of tracking information as needed.Collaborate with the Study Team on the development and readiness of sites eISF when utilized and act as primary point of contact for the sites and manage the Site Operations/CRO monitor access to eISF prior to SIV.Assist with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.Support & implement activities in Shared Investigator Platform to align with client strategy as it relates to the role.Coordinate translation of documents that are within scope with the preferred translation vendors

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