Study Monitor

22 hours ago

Swansea, United Kingdom Capilaux Full time

Overall Purpose:

As a Study Monitor, you will play a pivotal role in overseeing the progress of clinical and application research trials. You will ensure that all studies are conducted, recorded, and reported in compliance with protocols, SOPs, ICH-GCP, and applicable regulatory requirements. You will provide a global evaluation of all investigations commissioned and executed, acting as the crucial link between investigators and research personnel.

Why Join ?

I am seeking an exceptional individual who brings innovative ideas, a positive attitude, and a professional demeanor. You will thrive in this dynamic environment where your expertise will drive clinical research excellence. As a key member of the Clinical and Application Research Team, you will play a critical role in advancing our cutting-edge clinical trials and ensuring the highest standards of quality and compliance.



Key Responsibilities:

  • Study Oversight: Oversee clinical trial progress, ensuring compliance with regulatory standards and protocols.
  • Document Management: Prepare and manage essential study documentation, ensuring compliance from start-up to close-out.
  • Data Verification: Ensure accurate patient data recording across multiple investigations.
  • Investigator Training: Conduct on-site training, providing motivation and guidance to investigators.
  • Protocol Adherence: Monitor adherence to protocols, GCP, and internal SOPs, maintaining high standards.
  • Site Visits: Perform routine site visits and assessments to ensure optimal project execution.
  • Auditing: Complete detailed audits and verify activities at investigative sites, ensuring all projects meet deadlines.
  • Supply Management: Procure, store, and disseminate study supplies, ensuring accountability and proper dispensing.
  • Team Development: Mentor and train new department personnel, including competency testing, and identify areas for new training materials and SOPs.
  • Collaboration: Bridge the gap between Principal Investigators and research personnel, providing expert advice and making informed decisions to ensure project success.


Key Objectives/KPIs:

  • Motivation: Inspire and motivate the research team to achieve project targets.
  • Quality Assurance: Conduct QA/QC of investigator activities, ensuring regulatory compliance.
  • Timely Delivery: Ensure research staff meet targets and deliverables within set timelines.
  • Audits & Analysis: Perform trend analysis and audits to enhance trial execution.
  • Full Responsibility: Take ownership of all study monitoring duties, ensuring projects run optimally.
  • Training & Development: Identify and develop new training materials, SOPs, and documentation as necessary.


Required Skills, Experience, and Attributes:

Essential Attributes:

  • Academic Qualifications: Degree in a scientific subject.
  • Experience:
  • Proven clinical trial experience in a research setting.
  • Experience with Phase I-IV trials, with a preference for Phase II-III.
  • Regulatory Knowledge:
  • Working knowledge of EU Clinical Trials Directive, Medical Device Directive, UK Clinical Trials Regulations, ICH-GCP, GDPR, and Research Governance Framework Legislation.
  • Experience with EU Medical Device Regulation and BS EN ISO 14155 is preferred.
  • Organizational Skills: Strong ability to manage multiple priorities effectively.
  • Communication:
  • Excellent interpersonal skills.
  • Ability to communicate clearly and resolve conflicts collaboratively.
  • Attention to Detail: Operates with a high level of due diligence, thoroughly investigating and verifying issues.
  • Problem-Solving: Strong initiative and problem-solving skills, particularly under pressure.

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