Clinical Research Associate

Are you highly motivated by being able to make a difference to improving patients’ lives? Are you a high performing professional who can energize people around you? If yes, then continue reading and apply now!

In Novo Nordisk Korea, the position of Clinical Research Associate (CRA) provides you the opportunity to work in a high performing team to contribute directly towards the business results while creating values for the Diabetes patients.

About the Department

The Clinical, Medical and Regulatory (CMR) department is one of the key functions that enable the business strategy through effective execution of functional goals, in the areas of Clinical Research, Medical Affairs and Regulatory.

The Position

The Clinical Research Associate (CRA) oversees the leadership of site management for the selection (if applicable) and initiation of sites as well as conducting and closing activities of the appointed studies in compliance with local regulations, ICH-GCP (The International Conference on Harmonization guidelines define Good Clinical Practice), Novo Nordisk (NN) procedures and protocol requirements to ensure data quality and study subject protection. Looks after the recruitment at site level and delivers results that have a direct impact on the successful completion of the clinical programme.

The CRA coordinates with NN Korea CDC (Clinical Development Center) Project Manager/ Clinical Research Manager and communicates to them progress and critical issues that may impact trial progress. In some cases, the CRA may have direct contact with NN GD TMS(Global development Trial managers/managements).

The CRA primary tasks in site management will include:

• Manage clinical trial sites for the allocated phase 1-4 clinical trial/Non-interventional studies effectively and efficiently in compliance with NN SOP(standard operating procedures), ICH GCP, GPP (Good Production Practice), KGCP(Korea Good Clinical Practice) and local regulations
• Has good knowledge of trial product and trial protocol and train site staff in trial procedures, handling of trial product and documents with Therapeutic knowledge and general understanding of diseases and treatments
• Ensure trial’s deliverables in responsible sites by preparation, following up and timely updates of trial recruitment, site trial budget, site recruitment and retention strategy
• Efficient and accurate site selection visits (as appropriate) including analysis of site logistics, site performance/quality indicators

• Proactive use of IT Systems (e.g. CTMS, EDC) for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics team

Qualifications

• Minimum Bachelor’s degree in Medicine, Pharmacy, Nursing, Life Sciences or equivalent ICH GCP trained and if applicable, certified
• Min. 1year and above CRA experiences (Depending on the candidate experience level, Sr. CRA title will be applied)
• Fluent in written and spoken English with good communication skill
• Excellent IT skill including MS office Package (Word, Excel and PowerPoint)
• Good knowledge of ICH GCP, KGCP and other clinical research

Working at Novo Nordisk

We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

Contact

Upload your CV to our online career page (click on Apply and follow the instructions).

Deadline

Until the completion of recruitment.

Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.