"Clinical Research Associate / Senior Clinical Research Associate (f/m) - home based in Norway"
This is the great opportunity to start in an home-based CRA or Sr CRA position at Quintiles Norway! We are offering home office solutions throughout Norway, not only in the Oslo area.
There is a definite trend amongst our key customers to use our Global Functional Resourcing model to establish a virtual presence in a region in order to deliver clinical trial management. During the past few years, we have seen a period of steady growth, geographic spread and expansion of the spectrum of models. Quintiles GFR is at the very forefront of this wave of Clinical R&D growth.
Within our GFR model, you will gain direct and in-depth experience of working with a pharma client.
By establishing strong relationships with the involved investigators and the associated support functions on site, such as nurses, pharmacists etc. you become a real partner in our Phase II/III trials. You will be responsible for monitoring the progress of a trial by ensuring that ethical, legal and scientific standards, expressed in ICH/GCP (Good Clinical Practice) are being upheld at all stages. As a CRA you will cover different trials and sites in located throughout Norway.
Independent whether working from home or the office, you will be fully integrated into our global team and the opportunities this presents.
As a Home-Based Clinical Research Associate, you will travel to conduct monitoring over complex clinical study sites to assure adherence to good clinical practices, standard operating procedures, and study protocols. You will be responsible for multiple projects, working independently and on a team. You will participate in clinical training programs, staying abreast of industry developments.
Other responsibilities of the CRA include:
- Reviewing regulatory documents and preparing site visit reports
- Participating in the study development and start-up processes
- Reviewing and following study protocols
- Designing and/or reviewing CRFs
- Preparing informed consent forms and developing study documents
- Organizing and presenting at investigator meetings
- Working with management to develop project-specific CRA training
Required knowledge, skills and abilities
- Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
- In depth therapeutic and protocol knowledge as provided in company training
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
- Strong written and verbal communication skills in Norwegian including a good command of English language
- Excellent organizational and problem-solving skills
- Effective time management skills
- Ability to manage competing priorities
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
Minimum required education and experience
- Bachelor’s degree in a health care or other scientific discipline
- Over one year of on-site monitoring experience
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