Study Start Up Associate II
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.
We’re looking for a talented and energetic Site Start Up Associate to join our team in the United Kingdom. This will be an office based role in the United Kingdom with some flexibility to work from home. This is a permanent role.
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 including submissions in the United Kingdom
- Prior experience using computerized information systems preferred
- Ability to read, write, and speak fluent English
- Clinical trials support or pharmaceutical industry experience preferred
- Knowledge of ICH and local regulatory authority drug research and development regulations preferred