القائمة الرئيسية

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 Clinical Research Monitor At Medtronic

Clinical Research Monitor At Medtronic


Cairo, Egypt
Clinical

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

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