Clinical Research Associate

bioMérieux, a family-owned company headquartered in France, has grown to become a world leader in in vitro diagnostics. For almost 60 years, we have been developing innovative diagnostic solutions to improve public health worldwide. Today, our teams are spread across 44 countries and we deliver products in 160 countries with the support of a large distribution network. This includes our Oslo site,  SpinChip Diagnostics AS.

bioMérieux/SpinChip offers attractive conditions including company health care, health, travel and group life insurance, and a favorable canteen scheme. With us, you will have a varied and exciting working day with professional colleagues who are at the forefront of the world in their field. We are located in modern premises centrally located in Skøyen where the entire organization is gathered under one roof; management, production, research and development. With us, you will be part of an ambitious and professionally strong environment with dedicated employees who want to succeed together.

Are you our new Clinical Research Associate?

Would you like to help introduce a new and exciting diagnostic tool to the global market? We are developing an advanced diagnostic platform for point-of-care testing, and after several years of intense research and development, we are now working towards launch. We need to strengthen our clinical department with a Clinical Research Associate (CRA). You will help conduct clinical studies that are necessary to commercialize our products, and will play an important role in our clinical department.

Description of the position

The CRA will work with our Clinical Scientists to conduct clinical trials spondored by bioMérieux. The primary task of the CRA role is to be the primary contact between bioMérieux and study personnel at clinical sites in the studies. The CRA helps ensure that clinical trials are conducted in accordance with applicable regulatory requirements and the study plan. The CRA also contributes to developing the laboratory procedures to be used at the study sites during the conduct of the clinical trials and will be responsible for the logistics of the studies.

Both domestic and international travel is expected – up to 30%. The CRA will report to the Senior Manager Immunoassays, Clinical Affairs, based in the US, but will be based at our office in Skøyen, Oslo, as part of a team of two Clinical Scientists and a Clinical Project Manager.

Job Responsibilities:

Contribute to the planning and execution of clinical studies together with Clinical Scientists:

• Develop and write laboratory procedures that describe the activities in the study to be performed by the study sites

• Participate in training of site staff in study procedures

• Communicate with study sites

• Monitor the study sites (both remote and on site) to ensure that all study activities are performed in accordance with regulations, study plan and laboratory procedures

• Keep track of recruitment status at sites

• Keep track of logistics/use of study materials in the ongoing studies to ensure that sufficient equipment/study materials are available at all times

• Coordinate shipping and receiving of samples, equipment and study materials to/from all active sites and external partners

• Provide logistical, technical and regulatory support to bioMérieux/SpinChip and study personnel on site to ensure that all have access to the necessary equipment, training and materials to conduct the study as planned

• Contribute to the completion of the final study report

• Contribute to data management/troubleshooting and coordinate with relevant functions within the company to resolve issues or questions on site related to data management

• Contribute to relevant laboratory activities as required

• Attend scientific conferences as required

Qualifications:

• B.Sc. in life sciences, bioengineering, chemistry, biochemistry, biotechnology or equivalent, and preferably with 1-2 years of experience from immunoassay-based laboratory methods

• Previous experience from human clinical studies/research is an advantage

• You are independent, systematic and structured, and collaborate well with others

• Experience from project management is desirable

• Experience in writing scientific and technical texts

• Good computer skills and communication skills in Norwegian and English, both oral and written

• Experience with database software and project management tools is desirable

• Knowledge of IVDR, ISO20196:2019 and IHC/Good Study Practices is an advantage

Please contact us for more information. Please show your interest by registering your CV and application by clicking the "apply here" button as soon as possible. All inquiries will be treated confidentially.

If you are motivated by being part of our international CA team, working on meaningful projects and bringing new technology to market, we want to hear from you.