Closing Date: 09 Dec 16
Salary (£): Negotiable
• CRA/SCRA • Slovakia • Freelance
The source department of Chiltern acts in a similar way to that of a staffing solutions provider. Our client is a leading Pharmaceutical company, they are looking for a CRA/SCRA to join their team in Slovakia. Candidates will work on a freelance basis, the role is full time, home based.
• Performs/participates in study site selection visits in the investigational sites
• Performs Primary CRA function for eCRF studies during the set-up phase
• Prepares/collects all study site essential documents needed prior to study initiation in collaboration with the Clinical Project Assistant (CPA) and Start-Up/Regulatory Team
• Facilitates negotiation of site Clinical Trial Agreements (CTA) prepared by the Regional/Local Clinical Project leader (RCPL) or Start-Up/Regulatory Team
• Ensures that sites apply for and receive hospital/practice/institution approval (e.g. R&D).
• Organises/participates in study initiation meetings in which are provided scientific and technical knowledge concerning the study procedures and its organisation
• Works with RCPL, Lead CRA and CPA to prepare, organise and participate in investigator meetings.
• Assists the RCPL/CPA in maintaining and ensuring the completeness of the local study files, checking the country-level (when Lead CRA for studies with regional CPL) and centre-specific files at regular intervals and reconciling with the investigator study files
Candidates must be an experienced CRA
Appropriate education (life science degree / nursing qualification)
Knowledge of and experience with GCP and other regulations in force; ability to learn and apply SOPs
Good IT skills in, e.g. MS Office, are essential, for planning, tracking, communicating and reporting
To apply for this position please email your CV to email@example.com or for a confidential discussion please call Nicky on + 44 1753 216 729
Please note that if your experience does not mirror that of the requirements for this role you may not receive a response.
Candidates must be eligible to work in Slovakia
Keywords: SCRA, CRA, Senior Clinical Research Associate, Clinical Research Associate, Clinical Trials, Slovakia
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