Clinical Research Associate (CRA) - Maternity leave covers
Category: Clinical Development
Location: Ørestad, Capital Region of Denmark, DK
Clinical Development Centre Denmark (CDC DK)
This role is unordinary because it places you at the forefront of groundbreaking clinical research in primarily but not exclusively diabetes and obesity, areas where rapid innovation can directly transform patients' lives. You'll not only monitor trials but actively contribute to therapies with the potential to reshape global health outcomes.
Apply today
We currently have three maternity leave cover positions available: two running for a 7-month period until October 1st, and one lasting until the end of ****.
Your new role
In this exciting role you wil l manage clinical trial sites at every stage of the clinical trial process to a high quality in accordance with the c ompany's policies and procedures, relevant legislation and ICH GCP requirements whilst maintaining the standards of the Novo Nordisk Way. You will collaborate closely with clinical investigative site teams to deliver our clinical trials according to target. You will be accountable for data integrity, quality, patient safety and protection, regulatory compliance for all assigned sites, compliance to protocols, adherence to Good Clinical Practice, Clinical Trial Legislation, and local ethics requirements, as well as Novo Nordisk standard operating procedures (SOPs ).
The main line of communication with Investigator site teams
Conducting and documenting monitoring visits in accordance with the Monitoring Plan and Risk Indicator Reports, using risk-based quality principles
Driving activities with sites to achieve recruitment and retention targets
Managing of protocol compliance, IMP handling and data entry requirements at site
Travel will be required approximately 30% of the time including some overnight stays depending on the clinical site's location.
Your skills and qualifications
You are a very collaborative team player who is proactive and ready to help in challenging situations. Preferably you got a previous experience of monitoring trials in accordance with ICH GCP methodology as well as healthcare industry knowledge or customer service-based employment.
Moreover, you have the following requirements:
Bachelor's Degree level, life science or nursing qualification or other relevant experience and an excellent understanding of clinical trial procedures– ICH GCP, regulatory issues, SOPs
GCP Certification
#J-*****-Ljbffr