Clinical Site Activation Specialist

1 giorno fa

Florence, Toscana, Italia Plininger A tempo pieno

Clinical Trial Site Activation Role Overview

The Clinical Site Activation Partner 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.

Clinical Trial Site Activation Responsibilities

  • Initiate 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 Shared Investigator Platform (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.

Clinical Trial Conduct

  • Post site activation, initiate and coordinate activities and essential documents management with the investigator's sites towards the compilation of a high-quality documents and updates through the life cycle of a study such as the documents management for protocol amendments, FDA 1572/Attestation revisions, Ethics Committee annual approvals and other activities required during study conduct.
  • Ensure maintenance of IRB/Ethics and other committees' activities as applicable.
  • Responsible for timely filing of documents to Trial Master File and assisting with periodic quality review of study files for accuracy and completeness.
  • Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines.
  • SUPPORTS investigator sites, and study teams in preparation for and providing responses to site audits / inspections.

Internal & External Communication

  • Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests.
  • Attend study Start-up meeting and provide functional updates on a country and site level.
  • Establish tools for efficient updates to study team as needed regarding site status, issues, delays, approvals.
  • Disseminate Central or Local Ethics Approval to study team and Investigator Sites where applicable.

Clinical Trial Site Support

  • As needed, perform, awareness session with site personnel on Client requirements and to ensure ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and Client standards.
  • Identify and resolve investigator site issues within required timeframes; align with study team and local country colleagues on corrective and preventative actions to close open issues and to prevent recurrence / persistence of issues.

General

  • Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, system and process related training.
  • Adhere to EP and Client SOPs and processes.
  • A good understanding of the Site Activation requirements and processes within the country/region and be able to learn and potentially implement in more than one (1) country.

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