Unterstützung im Bereich Clinical Trial Administration - Medizin/Healthcare (11S-77983)

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Schlagworte

Beschreibung

Task:
- Management of all documents and logistical and administrative tasks related to trial start-up, execution and close out of clinical trials
- The CTA performs the technical regulatory document review
- The CTA ensures trial related activities are in compliance with SOPs, policies and local regulatory requirements
- Partners with the Medical Program Lead (MPL) to ensure overall site management and adherence to internal SOPs, policies and local regulatory requirements
- Supports the local study team in performing site feasibility and/or country feasibility
- Is emergency backup / has insight in Trial Management Systems (e.g. CTMS).
- In liaison with the MPL, ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes.
- Where applicable, works with investigational site staff to ensure accurate/complete regulatory documents are in place to expedite IEC/IRB or Health Authority (if applicable) approval process.
- Supports the MPL in providing the current and complete documents requested by the IEC/IRB and HA.
- Supports the MPL in collecting and maintaining all documents throughout the trial and post trial in both eTMF and paper files.
- Distributes, collect, review, and track documents, agreements and training documentation.
- Collects and tracks Financial Disclosure information at appropriate time points.
- Contributes input to the development of Trial Documents, or initiates development of documents for a single country trial.
- Supports local trial team activities in compliance with Standard Operating Procedures (SOP), Work Instructions (WI) and applicable regulations.
- Maintains and updates trial management systems - (e.g. local document repository
(regular filing on PC-drives), eTMF/LAF, Trial Master Source and Sharepoints).
- May submit requests for vendor services and may support vendor selection.
- Supports the MPLs in forecasting and managing of country/local trial budget to ensure accurate finance reporting and trial delivered within budget. Adheres to finance reporting deliverables and timelines.
- Supports planning a local/country investigator meeting.
- Supports conduct of local trial team meetings
- Reviews site and local vendor invoices as required
- Works with MPL to ensure CAPA is implemented for audits and inspection or any quality related issues.
- Assist in preparation for archiving.
- Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, study trial coordinators and other site staff and internal stakeholders.
- Actively contributes to process improvement;
- Contributes to optimization of daily processes.
- Complies with relevant training requirements.

Requirements (Must have):
- 2 years experience with CAPA
- 3 years experience with CTMS - Clinical Trial Management System
- 3 years experience with eTMF
- Experiences with documentations requested by IEC/IRB
- Experiences with IIS - Immunization Information System
- Experiences with NIS - National Immunization Survey
- 2 years of Sharepoint Experience
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Beginn:
Dauer:
Branche: Medizin/Healthcare
Start
11.2014
Dauer
6 Monate
Von
Allgeier Experts Consulting GmbH
Eingestellt
17.10.2014
Ansprechpartner:
Nicole Schütze
Projekt-ID:
793276
Vertragsart
Freiberuflich
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