Clinical Research Monitor

Cairo, Egypt

Job Description

Careers that Change Lives Medtronic is looking for an Clinical Research Monitor! Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. 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, Ethics Committee/Institutional Review Board (EC/IRB) policies and procedures and business policies. This position works under supervision as needed, working closely with study teams, site personnel, Medtronic field personnel and monitoring supervisor for resolution of site issues.

A Day in the Life We offer you a position where your responsibilities may include the following and other duties may be assigned:
  • 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
  • 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 personneltowards securing Investigator compliance
  • Understand the study protocol and accompanying backgroundinformation (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 or Master degree in life sciences, nursing or other health related disciplines
  • Fluent in English and Arabic
  • Two (2) years of Clinical Research monitoring experience preferred
  • Capable of clearly and effectively communicating verbally and in writing
  • Excellent interpersonal skills
  • Ability to work in a fast paced environment
  • High attention to detail and accuracy
  • Excellent problem solving skills
  • Competencies and essential skills in the following: cross functional relationships, decision making, execution/results/process improvement, customer satisfaction
  • Basic understanding of any applicable regulations (e.g., Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive, etc.)
  • Regulations/standards training (FDA, ISO, GCP and other country specific training as applicable)
  • Ability to handle and prioritize multiple therapeutic areas and projects simultaneously
  • Experience with word processing, spreadsheets, and databases applications (e.g., MS Word and Excel)
  • Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands
  • Experience of conducting clinical research activities in a regulated environment
  • Availability for national and international traveling

Nice to Haves
  • Knowledge of any other language
  • Proficient knowledge of medical terminology
  • Scientific/clinical knowledge needed to adequately monitor the trial (e.g. general therapeutic area education and training)
  • Business knowledge or experience with the medical/healthcare industry
  • Experience working in a team/matrix environment requiring strong working relationships

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.

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Job Detail

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  • Job Type:
    Full Time
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  • Job Location
    Cairo, Egypt
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