Senior Clinical Research Associate (Remote)

Copenhagen, Capital Region
Posted 15 hours ago
Healthcare

About the role

Job summary

This role involves working as a Freelance Senior Clinical Research Associate within a Clinical Development Services team, focusing on an upcoming ophthalmology project. The position is fully remote and aims to build a network of experienced professionals for future opportunities.

Qualifications

  • Bachelor’s Degree in life science or nursing, or equivalent
  • Over 5 years of independent on-site monitoring experience, with at least 1 year as an unmasked monitor
  • Preferred experience in ophthalmology, particularly with retina indications
  • Strong understanding of Good Clinical Practice regulations and ICH guidelines
  • Fluent in English and local language

Responsibilities

  • Monitor clinical trials on-site and remotely, ensuring compliance with regulations and protocols
  • Verify informed consent procedures and protocol adherence to protect study participants
  • Review CRFs and source documentation for accuracy
  • Manage investigational product accountability and oversight of site activities
  • Report findings and actions taken during monitoring visits
  • Maintain Investigator's Site File in accordance with guidelines
  • Participate in audits and inspections as needed
  • Assist in project tracking and CRA resource management

Skills

  • Excellent written and verbal communication skills
  • Strong organizational and technology skills
  • Ability to work independently and collaboratively in a team
  • Proactive, flexible, and detail-oriented with strong analytical skills

Education

  • Bachelor’s Degree in life science or nursing, or equivalent

Tools

  • Familiarity with electronic data capture systems and clinical trial management systems
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