Study Monitor

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.