Clinical Research Associate II

4 settimane fa

Milano, Lombardia, Italia Allucent A tempo pieno

Job Title: Clinical Research Associate II

About the Role:

We are seeking a highly skilled Clinical Research Associate II to join our team at Allucent. As a Clinical Research Associate II, you will be responsible for independently controlling and monitoring investigation sites, proactively detecting issues, and providing solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice.

Key Responsibilities:

  • Governs quality standards for trial monitoring activities.
  • Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. Adheres to project guidelines and Allucent SOPs for monitoring requirements.
  • Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
  • Tracks and supervises collection of ongoing study data for purpose of regular project status reporting.
  • Collects and reviews regulatory documents as required.
  • Prepares site visit reports and telephone contact reports.
  • Maintains and updates CTMS in compliance with SOPs and study-specific directives.
  • Acts as Document Owner for collected documents.
  • May participate in the start-up process including preparing Informed Consent forms, developing study documents, EC / CA submissions, and / or site contract management
  • Aims to pro-actively prevent and / or mitigate issues. Resolves site issues, including site recruitment challenges, and determines status for IP shipment.
  • Acts as the main line of communication between the project team and the site staff.
  • Works in collaboration with Allucent Centralized Monitoring Team to evaluate risk-based monitoring activities to facilitate oversight of the study conduct at the sites and prevent issues. Activities are related to but not limited to: Investigational Product supplies, non-IP study supplies, subject eligibility, protocol compliance, facilities, and PI oversight.
  • Identifies potential logistical/practical problems and support Project team to create solutions / contingency plans, with timeframes for resolution.
  • Ensures the continuous maintenance of the Trial Master File and Investigator Site File.
  • Assists the Project Manager (PM) and Clinical Team Leader (CTL) with generation of study specific forms for completion by CRA and Investigators and follow up with the teams to ensure timely completion and submission.
  • Works with Project Manager (PM); Clinical Team Leader (CTL), SSU (Study Start Up) team members or sponsor to ensure authorization of regulatory documents and site contracts.
  • Attends Investigator Meetings (IM) to include organizing and presenting at investigator meetings. and study specific training meetings.
  • May translate, coordinate translations or review completed translations of the essential documents as required.
  • May participates in feasibility and/or site identification activities. Contacts local opinion leaders, medical consultants or specified investigators and identifies sites with the potential for participation. May follow feasibility procedures for documentation of feasibilities performed in collaboration with the Study Start Up Department.
  • Where applicable, identifies the documentation required for review by Regulatory Authorities and Ethical Committees. May prepare Regulatory and Ethics Committee submissions working in conjunction with Study Start Up Department. Ensure written approvals are obtained and distributed appropriately prior to Site Initiation.
  • Prepares and attends an Assessment Visit with a more senior CRA, CTL or Clinical Research Manager as required.
  • May process interim and final payments to Investigators, including preliminary calculations, review and approval from Project Management, liaison with finance, logging trial expenditure, receipts, invoices, and income.
  • Assists the Project Team with the day-to-day management of critical studies as required, including attendance at team meetings.
  • Provides secondary in-house review of CRFs (if required).
  • Support site staff in preparation for study related site audits and inspections.
  • Where applicable, reports Quality Issues and supports the root cause analysis, writing of and resolution of the Corrective and Preventative Actions.
  • May be assigned other tasks / activities / responsibilities related to the study execution in the country.
  • May support initiatives in the country, GCO, and / or CTO to contribute to improvements and quality.
  • Must work both independently and in a team environment.

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