Clinical Trial Assistant
il y a 3 jours
**Clinical Trial Assistant**:
- Location:
Ghent, Belgium
- Contact:
Aurelie Petit
- Job type:
Contract
- Contact phone:
+32 10 68 53 32
- Industry:
Life Sciences, Clinical Research
The Clinical Trial Assistant (CTA) is responsible for assisting the team in Clinical and Exploratory Pharmacology activities by performing operational tasks associated with the coordination of set-up, conduct & closure of clinical trials.
**Responsibilities**
- Invoice Budget and invoice tracking for each vendor and overall study budget. Invoice payment can be delegated by CTM.
- Transparency reporting as required.
- Tracking of various vendor activities.
- Review of eCRF completion /Discrepancy resolution to ensure site tasks are performed in a timely manner and alert appropriate study team members for escalation.
- Prepare study status reports from appropriate tools (i.e., Protocol Deviation tracking, etc).
- Track study status reports.
- Track any study related equipment to/from vendor and site; place orders at study start and during study as needed.
- Maintain the study decisions and/or FAQ log.
- Create and maintain Who's Who.
- Track Regulatory submission status (HA/IRB/IEC).
- Support audit preparation activities.
- Sets-up and manages study specific webportal
- Sets-up, updates and retrieves and consolidate pertinent trial related information from internal systems (e.g. CTMS, Optime ) or correspondence, provides updates, as necessary, performs quality review and manages data privacy.
- Assesses and sets-up clinical site for the use of CDMS (e.g. OC RDC).
Collects study related documentation from clinical sites/providers (e.g. regulatory documents such as CVs, Financial Disclosures ), checks and performs quality control, prepares CSR appendices.
- Prepares, updates and distributes key trial information on the study progress and study materials/investigational products, performs quality control on study reports/documents (e.g. trial status, recruitment curves, newsletters, study Who's who ) using appropriate tools or templates.
- Prepares project related meetings (e.g. Site Initiation Visit, Study team meeting, investigators/CRA meetings), may present dedicated topics and draft the minutes if needed.
- Collaborates internally and externally with departments and sites regarding study related activities (e.g. feasibility assessments, consultancy and confidentiality agreement).
**Requirements**:
- A first experience in pharmaceutical industry and/or clinical related discipline, familiarity with medical terminology, general understanding of the R&D/Clinical Development process and previous exposure to GCPs is required.
- Good level in English, written and verbal communication.
Autonomous, capable of taking initiatives and responsibilities.
- Excellent interpersonal and communication skills.
- Detail and quality oriented.
- Ability to handle multiple tasks, to prioritize activities and deliver on time.
- Good organizational skills.
- Ability to work in team
- Good problem solving skills
- Master degree or relevant industry experience
- Existing right to work in Europe
**Benefits**
- Fulltime position
- 3 days on site, and 2 days remote
- A balanced salary package based on your capabilities and experience, including extra legal benefits
Vacancy number: 19206
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