Clinical Site Startup Specialist at Perspective Therapeutics | Torre
Clinical Site Startup Specialist
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Perspective Therapeutics

Clinical Site Startup Specialist

Perspective Therapeutics
Emma
Emma
You'll accelerate life-changing cancer therapies by meticulously launching clinical trial sites.
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Full-time

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Emma of Torre.ai
 29 days ago

Requirements and responsibilities

ObjectiveThe Clinical Site Startup Specialist plays a pivotal role in the successful initiation of clinical trials by overseeing and coordinating all activities related to site startup. This position involves meticulous management, tracking, and facilitation of processes, from site selection through the Site Initiation Visit (SIV) phase. The specialist will be responsible for ensuring seamless execution of various tasks, including regulatory document collection, site contract and budget negotiations, IRB submissions and approvals, equipment provisioning, and the completion of a comprehensive greenlight checklist for drug release. As the owner of the site’s contract and budget the clinical site startup specialist will also be responsible for processing any amendments that are needed to site budget or contract.Essential FunctionsRegulatory Document ManagementCollect, review, and track all required regulatory documents from selected trial sites.Ensure compliance with regulatory standards and guidelines.Site Contract and Budget NegotiationsEngage in negotiations with clinical trial sites for contracts and budgets.Collaborate with the clinical trial manager and legal and finance teams to finalize agreements.Execute amendments to contracts/budgets as needed.IRB Submissions and ApprovalsPrepare and submit central Institutional Review Board (IRB) application in collaboration with the site and study team.Tracks local IRB submissions and approvals.Facilitate communication between Perspective, sites and IRBs to obtain timely approvals.Equipment ProvisioningCoordinate the provisioning of necessary equipment at trial sites.Ensure that all equipment is compliant with trial protocols and regulations.Greenlight Checklist for Drug ReleaseExecute a comprehensive checklist for drug release in collaboration with relevant stakeholders.Confirm that all site startup activities are completed and meet the required standards before drug release.Communication and CollaborationMaintain open communication with internal and external stakeholders.Collaborate with cross-functional teams to address challenges and ensure a smooth startup process.Documentation and ReportingMaintain accurate and up-to-date records of all site startup activities.Generate reports for management and project teams as needed.File all essential documents in the study eTMFQualifications
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