Clinical Trial Assistant (EN - DU/FR)

Job Description

Responsibilities

• Preparation, support and attendance of meetings e.g. kick-off meetings, trial team meetings, handover meetings, investigator meetings and follow-up on assigned action items
• Set up and maintenance of share point, public drives, Microsoft Teams
• Support trial teams with the creation of presentations and communication, including distribution of documents for sign-off and follow-up
• Support in clinical trial payment process
• Support in submission process
• Investigational supplies support - communication and scheduling
• Enter information related to approvals in CTA database
• Supporting trial study teams in audits/inspections
• Provide inspection readiness related support
• Support the team with operational aspects of the trial e.g. maintenance of trackers, access/accounts request and cancellation for sites and vendors, generating/downloading suppliers reports (e.g. ACI, BlueSky, ALMAC), communication regarding documents/updates/access and training for all systems (eg. IRT, Clinergize, BRAVE, ERT, etc.)

• Preparation, ordering and shipping of documents/binders/ equipment/IMP and AxMP/other local requirements within countries
• Translation of documents
• Meetings, e.g Local Investigator Meetings
• Tracking of medical licenses
• Archiving of Site ISFs and Pharmacy files
• OPU Feasibility, incl. CDAs, follow-ups and completing of IDM BICTMS request forms
• Creation of shopping carts and management of POs
• Support in signature process for Clinical Trial Agreement

• Set up of trial countries and site personnel, incl. entering of relevant study/site staff responsibilities, start/end dates
• Responsible for site address/personnel change and notifications and updates to related forms, supplies, BICTMS updates
• Support CTM to make updates and maintain accuracy in BICTMS for planned and actual event dates, including ethics and regulatory approvals and ICF/protocol tracking
• Completing IDM BICTMS information request forms
• Running reports from BICTMS
• Support CTM with the completion/Review of Site Release Checklist, incl. ensuring that all required documentation for site release and initiation are present
• Validate/cross-check TMF and BICTMS information for consistency/ completeness
• Resolving COPI reports (e.g BICTMS, Clinergize), monthly QC document findings

• Essential records preparation of TMF on OPU/ROPU level
• Support in the TMF Documentation Vendor collaboration and communication
• Act as a TMF contributor by submitting records into the central TMF Staging Area and resolve any discrepancies prior to submission to the central TMF Staging Area
• Participate as appropriate in MIDI Trial Oversight Meetings and present potential TMF topics

• Ongoing Clinergize review for completeness and maintenance
• Facilitate collaboration and communication between trial site and TDS
• ISF creation and updates
• Table Of Content local adaptation
• Maintaining current Sponsor Contact List

Requirements

• Bachelor degree (e.g. medical assistant, or paramedical education) or relevant work experience in clinical research field
• Regulatory and / or Organisational Requirements: Act in compliance to internal and external standards (e.g. ICH-GCP, Good Documentation Practice, SOPs, WIs and local procedures). Ensure that all interactions and engagements are carried out with the highest ethical and professional standards.
• Communication (cultural-sensitive, clear and transparent)
• Team work
• Good English communication skills in writing, speaking and reading
• Ability to prioritize, coordinate and follow-up
• Understanding of legal/regulatory environment concerning sponsor TMF and ISF Management

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