Company: Docs Global (Continental Europe)
Reference: Ref AS-020068
Closing Date: 25 Feb 17
Salary (£): Competitive
Benefits: Excellent & Comprehensive
The Clinical Trial Assistant (CTA) supports the Local Trial Manager and Site Manager to ensure optimal management of all documents with logistical and administrative tasks related to trial start-up, execution and closing of clinical trials.
Roles & Responsibilities of the position
- Partners with the LTM and Site Manager 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.
- Maintains site level protocol information in Trial Management Systems (e.g. CTMS).
- In liaison with the LTM, 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 LTM or, where applicable the SM, in providing the current and complete documents requested by the IEC/IRB and HA.
- Supports the SM/LTM in collecting and maintaining all documents throughout the trial and post-trial in both eTMF (i.e., IF/LAF sections) and paper files.
- Distributes, collect, review, and track regulatory documents, agreements and training documentation.
- Collects and tracks Financial Disclosure information at appropriate time points.
- Complies with relevant training requirements.
- A Bachelors degree is prefered.
- Preferably 2 years relevant clinical trial experience or equivalent.
- Proficient in English language.
- Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint).
- Strong interpersonal and negotiating skills.
- Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner.
Interested? For more information contact:
+32 (0)16 394733
2 Globeside, Globeside Business Park
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