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Clinical Research Monitor, UK

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Clinical
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19000CJK Requisition #
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CLINICAL RESEARCH MONITOR

Careers that Change Lives

The Clinical Research Monitor is responsible for the oversight of clinical research conducted at investigational sites to ensure compliance with study protocols, applicable regulatory standards, IRB/EC policies and procedures and business policies.  

A Day in the Life
  • Perform site monitoring visits in accordance with the study Monitoring Plan to ensure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB/EC, and Medtronic standards, guidelines and policies
  • Communicate visit findings with site personnel and complete a written letter for distribution to the Principal Investigator and appropriate site personnel for follow-up
  • Prepare site visit reports and correspondence for all visits conducted in accordance with the study Monitoring Plan (through a CTMS)
  • Identify site needs, provide solutions to facilitate the clinical trial process
  • Act as a primary point of contact for study sites as requested
  • Assist in initial and ongoing site personnel training as required
  • Identification and escalation of protocol deviations, discrepancies in data, and non-compliance to study protocols, applicable regulations, Good Clinical Practices and Standard Operating Procedures
  • Collaborates with monitoring management and study team personnel towards securing Investigator compliance
  • Understand the study protocol and accompanying background information (e.g., Investigator Brochure, Report of Prior Investigations etc.)
  • Possess a working knowledge of disease state and investigational product
  • Possess understanding of regulatory requirements
  • Attend internal department and team meeting as requested
  • Adhere to all applicable Medtronic policies and procedures

In addition, the Clinical Research Monitor may:
  • Attend Investigator and/or Coordinator meetings
  • Provide input into final study site selection
  • Be involved in site management activities
Be assigned lead monitor responsibilities which include but are not limited to:
  • Providing input on study protocol, CRFs and other study documents
  • Authoring or assisting in the creation of Monitoring Plans, monitoring section of Data Management Plans, and source document worksheets
  • Assisting in the creation of corrective and preventive action plans and trending reports
  • Managing site assignments in collaboration with manager
  • Facilitating communication and information flow between assigned project teams and assigned monitors on project
  • Ensuring monitors are trained, current with project requirements and understand study milestones
  • Overseeing action item tracking and resolution status
  • Performing co-monitoring visits as needed
  • Ensuring Monitoring Plan requirements are being met and escalates risks
  • Attending Core/Study team meetings
Must Haves
  • Bachelor’s Degree in life sciences, nursing or other health related disciplines
  • Proven Clinical Research Associate / Monitoring experience 
  • Capable of clearly and effectively communicating verbally and in writing
  • Excellent interpersonal skills
  • Experience working in a team/matrix environment requiring strong working relationship
  • Ability to work in a fast paced environment
  • Ability to handle and prioritize multiple therapeutic areas and projects simultaneously
  • High attention to detail and accuracy
  • Good understanding of  applicable regulations (e.g., Good Clinical Practices, ICH guidelines, FDA, EU Directive, etc.) Experience of conducting clinical research activities in a regulated environment
Nice to Haves
  • Previous experience working in medical devices
  • Completed all types of monitoring visits from Site Selection to Close Out
  • Willing to travel throughout the UK (and Ireland if required)
Your Answer 
Is this the position you were waiting for? Then please apply directly via the apply button! 

About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of  what technology, therapies and services can do to help alleviate pain, restore health and extend life.
We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. 
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. 
Let’s work together to address universal healthcare needs and improve patients’ lives.Help us shape the future.

Founded in 1949 as a medical repair company, we're now among the world's largest medical technology, services and solutions companies, employing more than 86,000 people worldwide, serving physicians, hospitals and patients in over 155 countries. 
Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your own career. Join us in our commitment to take healthcare Further, Together.


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