At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions. Diabetes poses one of today’s biggest global health challenges. We work for a future where fewer people get diabetes, everyone with diabetes is diagnosed, and everyone who is diagnosed receives adequate treatment and can live a life with as few limitations as po...
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The CRA is the primary point of contact between site staff and Novo Nordisk. In this role the CRA acts as ambassador for the company and contributes to making Novo Nordisk the preferred partner.
The CRA is responsible for taking leadership of site management for the selection and initiation of sites as well as conduct and closing activities of the appointed studies in compliance with local regulations, ICH- GCP, Novo Nordisk procedures and protocol requirements to ensure data quality and study subject protection.
The CRA is responsible for managing the site to meet patient recruitment rate and target.
The CRA thereby delivers results that have direct impact on the successful completion of the clinical programme.
The CRA coordinates with LTM and RTM and communicates to them progress and critical issues that may impair trial progress.
Qualifications
To be effective in this role you need:
Bachelor’s degree or above of Medical Science, e.g. medical, pharmacy, nursing, etc.
Adequate English verbal and written skills
Requires a minimum of one year clinical trial experience within pharmaceuticals industry or CRO; preferably in clinical monitoring. Other experience may also be relevant, e.g. as a Clinical Research Assistance” at CRO.
Knowledge of Good Clinical Practice (GCPs), ICH Guidelines, and local regulations, research process and scientific knowledge as relates to clinical trial conduct.
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