Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy.
Post: Clinical Research Associate – Pipeline
Job Description
- The CRA coordinates 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
- Has good knowledge of trial product and trial protocol and train site staff in trial procedures, handling of trial product and documents
- 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
- Guide site staff in preventing deviations that will compromise integrity and quality of trial-conduct
- Train site staff in safety information handling and systems
- Meet all local and company requirement with respect to safety reporting
- Collaborate with Data Management in resolving queries
- Manage trial product requirements incl. temperature deviations incl. training of site staff
- Motivate and build strong relations with site personnel to ensure NN is their preferred provider
- Ensure collaboration with and deliveries from vendors locally
- Ensure that the documents are timely collected and in compliance with NNSOP and regulatory requirements
- Attendance at Investigators Meetings and Monitors Meetings to ensure relations with sites as well as active participation
The CRA has major influence on the reputation and the results of the department, Business Area, Region, and company through their motivational interaction with the site staff. Internal support is provided by being service-minded, meeting deadlines and by contributing to meet the targets vis-a-vis continuous improvement of the quality of the outcome from the area in order to constantly optimise clinical development at Novo Nordisk. The CRA should always bear in mind that customer satisfaction is the ultimate departmental and individual goal. Efficiency, quality and job satisfaction should always be safeguarded to the same extent.
The CRA has substantial influence on department, project and hence NN results since each clinical trial is a unique contribution to the successful marketing of NN products. The recruitment of suitable patients according to agreed targets for time and quality is the basis for getting all contributions finished in time and for reaching a quality level being acceptable for approval or sales of NN products.
The CRA should actively contribute to adequate and timely information of all concerned within and outside the department.
Candidate Profile
- Graduate in Medicine, Science, Pharmacy or other relevant
- ICH GCP trained and if applicable certified
- Additional qualification on clinical research would be preferred.
- 2 – 4 years of experience as a CRA
- Experience in 1-2 multinational clinical trials phase 2-3 from site initiation till site closure.
- 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.
Additional Information
Qualification: B.Pharmacy, BSc
Experience: 2 – 4 years
Location: Bangalore
End Date : 30th July, 2023
