Clinical Research Associate (Scandinavia)

Qmed is looking for a CRA with a solid background in clinical research. We specialise in medical devices and work across Scandinavia and Europe for many different products and indications.

Our CRAs work both independently and in a team and are involved in submissions to EC/Regulatory Authorities as well as monitoring at clinical trial sites.

This can be a home-based position in Denmark, Sweden or Norway. Our office is based in Copenhagen. You need to be fluent in Danish and/or Swedish, with a good command of English.

Your main responsibilities will include, but are not limited to:

Monitoring all aspects of the clinical trial project, while ensuring subject safety and data integrity
Maintaining clinical trial compliance in accordance with ICH GCP, ISO 14155, and other applicable regulations.
Verifying proper and complete informed consent.
Ensuring proper medical device accountability.
Assisting clinical site staff and answering any questions.
Reviewing medical records and verifying clinical data against case report forms.
Assist with the development of clinical research procedures and tools.
Completing regulatory submissions for competent authorities and ethics committees.

What we look for in a candidate:

You have a strong medical and clinical research background
You hold a university degree in life-science or equivalent or have a strong medical/nursing background and at least 2 years of CRA work.
You have excellent organizational and prioritization skills and possess a good attention to detail. It is essential that you can act independently, but also contribute to a team.
You have excellent cross-cultural awareness and like to contribute to cross-functional work.
Travelling is an integral part of the CRA job and is primarily in Scandinavia
A strong command of the English and Danish language is required, preferably also Swedish.
You understand clinical trial processes and possess knowledge of ICH GCP and/or ISO 14155.
You have solid IT skills.

Sounds like you?

If you have any questions regarding the position, you are welcome to contact us at +45 56 64 1010 or sjo@qmed-consulting.com.
Start date is as soon as possible, but we will wait for the right candidate.

We look forward to hearing from you.