Role : Clinical Research Associate (CRA)
Company : Novo Nordisk
Location : Mumbai, India
Job category : Clinical Development and Medical
Department : Clinical Development Centre
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.
- The CRA is 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,
- 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 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
Qualification :
- 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
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Here are some potential interview questions along with sample answers for the Clinical Research Associate (CRA) position at Novo Nordisk in Mumbai :
1. Can you provide an overview of your experience as a Clinical Research Associate?
Sample Answer: Certainly. I have a strong background in clinical research, particularly as a Clinical Research Associate. Over the past 3 years, I have worked with two multinational pharmaceutical companies, where I played a pivotal role in overseeing phase 2-3 clinical trials from site initiation to closure. My responsibilities included site management, patient recruitment strategy development, training site staff, and ensuring compliance with local regulations and ICH GCP guidelines.
2. What do you see as the key responsibilities of a Clinical Research Associate in the context of Novo Nordisk’s Clinical Development Centre?
Sample Answer: In the role of a Clinical Research Associate at Novo Nordisk’s Clinical Development Centre, the key responsibilities include acting as a liaison between the site staff and the company, managing site selection and initiation, conducting and closing activities for appointed studies while adhering to local regulations and quality standards. Additionally, the CRA must effectively communicate progress and issues to the relevant teams and ensure the integrity and quality of trial conduct.
3. How do you ensure efficient patient recruitment strategies and what steps do you take to mitigate challenges in this area?
Sample Answer: Efficient patient recruitment is essential for the success of clinical trials. To ensure this, I work closely with site staff to devise effective recruitment strategies. This includes leveraging local networks, engaging with patient advocacy groups, and implementing targeted advertising. If challenges arise, I proactively analyze the root causes and implement mitigation actions. For instance, if enrollment is slow, I collaborate with the team to adjust recruitment tactics, refine inclusion/exclusion criteria, and enhance patient engagement efforts.
4. Can you describe your experience in training site staff on trial procedures and handling trial products?
Sample Answer: Certainly. Training site staff is crucial for maintaining protocol adherence and ensuring data integrity. I’ve conducted comprehensive training sessions where I’ve explained trial procedures, proper handling of trial products, and the importance of accurate documentation. These sessions not only ensure that the team is well-informed but also help in preventing deviations that could compromise the quality of trial conduct.
5. How do you ensure compliance with ICH GCP guidelines and local regulations during clinical trials?
Sample Answer: Compliance with ICH GCP guidelines and local regulations is fundamental to ethical and quality research. I maintain a deep understanding of these guidelines and regulations, regularly reviewing updates and changes. I conduct thorough site monitoring visits to verify source data, ensure proper documentation, and address any deviations promptly. In collaboration with the data management/logistics team, I utilize IT systems to streamline preparation and conduct of site visits while adhering to regulatory standards.
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