Clinical Research Associate

4 weeks ago

Ahmedabad, India Novo Nordisk AS Full time

Department – Clinical Medical Regulatory (CMR)

Do you want to be a part of a high performing team in Novo Nordisk that plays a critical role in driving the success of the business? Do you have what it takes: the right drive, a sharp mind, customer orientation, openness and focus on what matters and a genuine interest in working with people? If you find challenges inspiring and want to drive innovation within a multifaceted and inspiring working environment, you may be our new CRA for the Clinical Medical Regulatory team based at Ahmedabad. If you have what it takes to be a part of Novo Nordisk team, Apply now

The position

The Clinical Research Associate (CRA) is the primary point of contact between site staff and Novo Nordisk. In this role the CRA acts as ambassador for the company. As a CRA you will be responsible for:

Taking leadership of site management for the selection (if applicable) and initiation of sites as well as conduction and closing activities of the appointed studies in compliance with local regulations, ICH- GCP, NN procedures and protocol requirements to ensure data quality and study subject protection. The CRA is as such responsible for recruitment at site level. The CRA thereby delivers results that have a direct impact on the successful completion of the clinical programme. Coordinating with CRM and RTM and communicates to them progress and critical issues that may impair trial progress. In some cases, the CRA may have direct contact with the ITM. Efficient and accurate site selection visits (as appropriate including analysis of site logistics, site performance/quality indicators). Accountability for patient recruitment strategies, including implementation of mitigation actions. Visit trial sites regularly in accordance with the protocol to perform monitoring activities required. Proactive use of IT Systems (e.g., IMPACT, EDC) for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics team.

Qualifications

To be successful in this role, you should have the following qualifications:

You should be graduate in Medicine, Science, Pharmacy or another relevant field preferred. Certified in ICH GCP trained is preferred. Additional qualification on clinical research would be preferred. 2 - 4 years of experience as a Clinical Research Associate. Experience in 1-2 multinational clinical trials phase 2-3 from site initiation till site closure preferred.

About the department

The Clinical Research department at Novo Nordisk India is based in Ahmedabad. We have a team of dedicated professionals working on cutting-edge clinical trials in the field of diabetes and other serious chronic diseases. Our department is fast-paced and dynamic, with a focus on delivering high-quality clinical research projects. Join us and be part of a team that is making a difference in the lives of patients around the world.

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