Associate Clinical Research Monitor – Nordics region

Details

  • Category: Medical devices
  • Location: Work from home
  • Starting date: Jun 01, 2021
  • Domain of experience: Clinical Research, Clinical Trial
  • Level required: Junior
  • Years of experience: Minimum 2 years

Your Role

Workplace: Homebased
Contract: Permanent contract (internal recruitment)
Start date: ASAP

As Associate Clinical Research Monitor for the Nordics region, you will be responsible to monitor clinical research conducted at investigational sites mainly in Sweden and Norway. One of the main missions will be to ensure compliance with study protocols, applicable regulatory standards, IRB/EC policies and procedures.

For this role, you will have the opportunity to work from home, independently and to travel up to 80%.

Your Tasks

• Ensure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB/EC, and relevant standards, guidelines and policies
• Perform site monitoring visits in accordance with the study Monitoring
• Work closely with study teams, site personnel, company field personnel and management for resolution of site issues
• Communicate visit findings with site personnel and provide feedbacks to the Principal Investigator and appropriate site contacts for follow-up
• Identify site needs, provide solutions to facilitate the clinical trial process
• Act as a primary point of contact for study sites
• Assist in initial and ongoing site personnel training
• Identification and escalation of protocol deviations, discrepancies in data, and non-compliance to study protocols, applicable regulations, GCP and SOP

Your Profile

• Degree in life sciences, nursing or other health related disciplines
• Experience in Clinical Research related activities such as Clinical Trial
• One year of Clinical Research Monitoring preferred
• Administration, handling of investigational products preferred
• Possess understanding of regulatory requirements
• Willingness to travel up to 80%
• English mandatory, Swedish or Norwegian would be a strong plus

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