Clinical Trial Assistant

**Clinical Trial Assistant (EN - DU/FR)**:

- Location:
Auderghem, Belgium
- Contact:
Aurelie Petit
- Job type:
Permanent
- Contact phone:
+32 25 88 16 02
- 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. 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.)

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, 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 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/cross-check 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 (cultural-sensitive, clear and tra