Clinical Research Associate - South Korea - Novo Nordisk AS와 관련된 현재 작업


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Clinical Research Associate

4 개월전에


South Korea Novo Nordisk AS 풀타임

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 site management for the selection, initiation, conduct, and closure of studies, ensuring compliance with local regulations, ICH-GCP, and Novo Nordisk (NN) procedures to maintain data quality and safety of study subjects. The CRA is in sharge of the site-level recruitment and achieving results crucial to the clinical program's success. They align with NN Korea CDC Project Manager/Clinical Research Manager, reporting progress and critical issues, and may sometimes interact directly with NN Global Development Trial Managers.
The CRA primary tasks in site management will include:

Manage clinical trial sites for allocated phase 1-4 clinical trials and 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. Possess good knowledge of trial products and protocols, and train site staff in trial procedures, handling of trial products, and documents, with therapeutic knowledge and a general understanding of diseases and treatments. Ensure trial deliverables at assigned sites by preparing, following up, and providing timely updates on trial recruitment, site trial budget, and site recruitment and retention strategy. Conduct efficient and accurate site selection visits (as appropriate), including analysis of site logistics and site performance/quality indicators. Proactively use IT systems (e.g., CTMS, EDC) for preparation and conduct of site visits, as well as source data verification in collaboration with the data management/logistics team. 

Qualifications

Minimum bachelor’s degree in medicine, Pharmacy, Nursing, Life Sciences, or equivalent. ICH GCP trained and, if applicable, certified. Minimum 1 year of CRA experience (Senior CRA title may be applied depending on the candidate's experience level). Fluent in written and spoken English with good communication skills. Excellent IT skills, including proficiency in the MS Office package (Word, Excel, and PowerPoint). Good knowledge of ICH GCP, KGCP, and other clinical research guidelines.