Company: Premier Research
Reference: MKS Spanish SSUA
Closing Date: 03 Feb 17
Salary (£): Competitive
Premier Research helps highly innovative biopharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research.
The Madrid, Spain office of Premier Research is looking for a talented and energetic Site Start Up Associate to join our team! You'll be accountable for:
Quality deliverables at the country level for site start-up in one or more components
Forecasting submission/approval timelines and ensuring they are adhered to.
Essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines
Progressing and tracking site recruitment and approvals according to study timelines
Ensuring accuracy and completeness of trial master file documents submitted during start-up and performs a QC review of files before transfer to Maintenance for filing in TMF
Collecting information on submission deadlines and timeline metrics for Regulatory Authority, Ethics Committees and other local bodies.
Setting up and maintaining a country folder with country Ethics Committees and local authority addresses and requirements
Documenting QC of eTMF from the Study Start-Up phase or other sections where the Start-up Associate is acting as document owner as the final deliverable to the client
You'll need this to be considered:
BSc, MSc or equivalent
Prior experience in Clinical Research with experience in start-up activities
Prior experience using computerized information systems preferred
Ability to read, write, and speak fluent English and French
Clinical trials support or pharmaceutical industry experience preferred
Office based or homebased
Knowledge of ICH and local regulatory authority drug research and development regulations preferred
This position is offered on a 6 month contract, office based from Madrid.
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