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Research Associate Lead

2 months ago

Swansea, United Kingdom Smart Solutions Recruitment Full time
SmartPro are working with an award winning manufacturer who are recruiting a Research Associate Lead to join the team in Swansea. The successful post holder will provide assistance in preparing study documentation for trials, IRB/IEC submissions and documentation for regulatory dossiers.
Key Responsibilities of the Research Associate Lead:
* Motivate research team.
* QA/QC investigators daily activities; ensuring compliance with CIP and regulatory compliance.
* Ensure research staff achieve targets and deliverables in a timely manner.
* Conduct detailed audits and trend analysis on key elements of trial execution; bridge the gap.
* Assume full study monitor responsibility.
* Procure, store, and disseminate study supplies (dispensing and accountability), including investigational devices.
* Induct, train and mentor new department personnel, including competency testing.
* Identify and devise new training materials as deemed appropriate.
* Identify and devise new departmental SOPs/WI and template documentation, as deemed appropriate
Requirements of the Research Associate Lead:
* Solid degree in scientific subject/
* Experience in a clinical research setting; proven clinical trial experience.
* Experience in Phase I-IV trials; Phase II - III is preferred.
* Working knowledge of EU Clinical Trials Directive, Medical Device Directive, UK Clinical Trials Regulations, Principles of ICH-GCP, GDPR and Research Governance Framework Legislation with proven ability to apply these to the coordination of clinical trials.
* Understanding of current EU Medical Device Regulation.
* Working knowledge of BS EN ISO 14155 is preferred.
* Experience working effectively in a team/matrix environment.
* Proven ability to manage multiple priorities and communicate effectively.
What you will get:
* Attractive starting salary between £30,000.00
* Permanent Contract with career progression
* Excellent company package including workplace pension, life assurance, product discounts and healthcare plan.
If you are passionate about research and possess the required skills, we encourage you to apply for this exciting opportunity as a Research Associate Lead