Clinical Trial Assistant

il y a 2 semaines

Auderghem, Région de Bruxelles, Belgique Oxford Global Resources Temps plein

Clinical Trial Assistant (EN - DU/FR):

  • Location:
Auderghem, Belgium

  • Contact:
Aurelie Petit

  • Job type:
Permanent

  • Contact phone:
  • Industry:
Pharmaceutical

Our Pharma client is looking to reinforce the their with a Clinical Trial Assistant - CTA. Do you have a first experience in the clinical /health care field ? Additionally, you are fluent in English, Dutch and/or French ? Then this may be for you

Job Description The MIDI Clinical Trial Assistant (MCTA) works within the MIDI Clinical Operations team and is responsible for adequate administrative, logistic and operational support to clinical trials from start-up until completion, within defined timelines and in accordance with ICH-GCP, other ethical and regulatory requirements and Client procedural documents.

A MCTA works on one or several clinical trials in collaboration with trial team members as well as with the investigational sites and vendors involved in the clinical trials.

A CTA can have an additional role and/or can take on an expert role/task (e.g. Payment Manager, Investigator Database Manager or Contract Manager) and/or can be involved in local country activities for trial without being assigned to the clinical trial.

Responsibilities
Logistic, administrative and operational support

  • Preparation, support and attendance of meetings e.g. kickoff meetings, trial team meetings, handover meetings, investigator meetings and followup 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 signoff and followup
  • 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.)

If applicable support and/or coordinate local country activities:

  • 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, followups 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 and maintenance of BICTMS on country/site level

  • 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/crosscheck TMF and BICTMS information for consistency/ completeness
  • Resolving COPI reports (e.g BICTMS, Clinergize), monthly QC document findings
Support in the maintenance and oversight of the Trial Master File

  • 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
Support in the maintenance and oversight of Clinergize and ISF related activities

  • 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 (culturalsensitive, clear and tra