Job Description
We are thrilled to offer an outstanding opportunity for a Study Monitor to join our client’s dynamic team at their Factory site in Swansea. In this role, you will conduct routine site visits, assessing study progress, and fostering collaboration between Principal Investigators and research personnel. Additionally, you will oversee routine close-out activities and conduct thorough audits to ensure compliance at investigative sites.
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The Role
You will be pivotal in overseeing the progress of clinical trials and research endeavours. You will ensure that all research activities are meticulously conducted, documented, and reported in strict adherence to Protocols, SOPs, ICH-GCP guidelines, and relevant regulatory mandates. Moreover, you will provide a comprehensive global evaluation of all commissioned investigations, ensuring optimal execution and compliance across diverse projects.
Key Responsibilities:
• Motivate and support the research team to achieve study objectives.
• Ensure daily activities of investigators comply with CIP and regulatory standards.
• Facilitate timely achievement of targets and deliverables by research staff.
• Conduct detailed audits and trend analysis to enhance trial execution efficiency.
• Assume full responsibility as the study monitor, ensuring seamless project management.
• Manage procurement, storage, and distribution of study supplies, including investigational devices.
• Facilitate induction, training, and mentorship of new department personnel, conducting competency assessments as needed.
• Develop and implement new training materials, SOPs, and documentation templates to optimise departmental processes.
Additional requirements:
• Possession of a solid degree in a scientific discipline.
• Demonstrated experience in clinical research, with a proven track record in clinical trial management.
• Proficiency in Phase I-IV trials, with a preference for Phase II - III experience.
• Thorough understanding of EU Clinical Trials Directive, Medical Device Directive, UK Clinical Trials Regulations, ICH-GCP principles, GDPR, and Research Governance Framework Legislation.
• Familiarity with current EU Medical Device Regulation and BS EN ISO 14155 standards.
• Proven ability to thrive in a team-oriented and matrix environment, effectively managing multiple priorities and communicating with stakeholders.
• Exceptional organisational skills coupled with a meticulous attention to detail.
• Outstanding communication abilities, facilitating effective conflict resolution and collaborative problem-solving.
• Diligent and assiduous approach to investigations, ensuring thorough verification of issues.
Join our client’s team and contribute to groundbreaking clinical research endeavours, where your expertise and dedication make a tangible difference in advancing healthcare innovation.