Freelance Clinical Research Associate

Dokumeds is looking for highly motivated and proactive clinical research professionals in position of Freelance Clinical Research Associate (CRA) in Europe.

Freelance CRA is responsible for all aspects of study site management including site selection, initiation, routine monitoring, close-out and maintenance of study files. Freelance CRA also ensures the quality and integrity of data, compliance with relevant SOPs and regulatory requirements and study completion on time and within budget.

Main responsibilities:

  • Site administration and site monitoring responsibility for assigned clinical studies according to Dokumeds and Sponsor Standard Operating Procedures, legal requirements and ICH-GCP Guidelines
  • Conduct of country and site feasibility
  • Site initiation, routine monitoring and close-out visits
  • Preparation and submissions to Ethics Committees/Regulatory Authorities
  • Assistance in site contract management

Requirements:

  • University degree in medicine, pharmacy, nursing or life science
  • Minimum 2 years of previous on-site monitoring experience in CRO or Pharma company; previous freelancing experience will be considered asadvantage
  • Previous experience in preparation and submissions to Ethics Committees/ Regulatory Authorities
  • Thorough knowledge of ICH-GCP guidelines including an understanding of local regulatory requirements
  • Excellent knowledge of the country of residence and English languages
  • Availability to travel
  • Computer literacy
  • Driving license
  • Strong organizational, communication and teamwork skills

We offer:

  • A job with daily exciting challenges in a highly qualified and international team
  • Employee-friendly work environment
  • Competitive salary
  • Opportunity to learn and grow professionally in Clinical Research field
To apply for this position email us your CV along with a cover letter to cv@dokumeds.com.