Clinical Research Associate Job @ Novo Nordisk – Pharma Apply
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Novo Nordisk Clinical Research Associate – WISE vacancy, Pharmacy job opening 2023, M Pharma job opening 2023, Pharmacy job opening 2023, Novo Nordisk job opening 2023, Pharma job opening 2023, Pharmacy job opening. Intrested and eligible candidates may check out all the details
Job Title: Clinical Research Associate – WISE
Category: Clinical Development and Medical
Location: Bangalore, Karnataka, IN
- Graduate in 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
Key areas of responsibility:
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, ICH- GCP, NNprocedures 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.
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.
The CRA responsibilities in site management include:
- 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
- Quality responsible person at the site
- Timeliness in deliveries through process planning and goal setting
- Identify potential risks and proactively take action to prevent and as needed, mitigate
Adeptness in ALL trial management-related IT systems (e.g. EDC, IVRS, FIRECREST, GHN, mynovotrial.com etc…)
- Therapeutic knowledge and general understanding of diseases and treatments
- Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements
- Support audit and inspections at sites as applicable
- Proficient use of NN systems (e.g. IMPACT, CATS)
- Perform/review/correct translation of trial related documents
- Coordinate with the regulatory team for HA dossier preparation and submission.
- Coordinate with CRM for EC dossier preparation and submission.
- Send follow up letter to the site as per NN timelines.
- Participate in and contribute to investigator monitoring meetings and audit and inspection as and when required.
Important Interview Questions and Answers for the above job role:
- What do you think are the key responsibilities of a Clinical Research Associate (CRA)?
Answer: The key responsibilities of a CRA include site management, recruitment of study subjects, conduction and closing of clinical trials in compliance with regulations, data quality assurance, and subject protection. The CRA acts as an ambassador for the company, maintains strong relationships with site personnel, and collaborates with vendors.
2. What experience do you have as a CRA, and how would you apply that to this position?
Answer: I have 3 years of experience as a CRA in multinational clinical trials. In my previous roles, I have led site management, trained site staff on trial procedures and handling of trial products and documents, ensured compliance with local and global SOPs, GCP, and regulatory requirements, and collaborated with data management in resolving queries.
3. How do you manage patient recruitment strategies, and what mitigation actions have you implemented in the past?
Answer: To manage patient recruitment strategies, I conduct efficient and accurate site selection visits, guide site staff in preventing deviations that will compromise the integrity and quality of trial-conduct, and identify potential risks and proactively take action to prevent and mitigate them. I also hold good knowledge of trial products and trial protocols and train site staff accordingly. In the past, I have implemented mitigation actions such as advertising the study on social media platforms, reaching out to patient advocacy groups, and offering incentives to participants.
4. Can you explain how you ensure compliance with safety reporting requirements at the site level?
Answer: To ensure compliance with safety reporting requirements, I train site staff in safety information handling and systems, meet all local and company requirements with respect to safety reporting, and collaborate with data management in resolving safety queries. I also manage trial product requirements, including temperature deviations, and provide training to site staff on this matter.
5. How do you handle potential deviations that could compromise the integrity and quality of trial conduct?
Answer: To handle potential deviations, I guide site staff in preventing deviations that will compromise the integrity and quality of trial-conduct, maintain good knowledge of trial product and trial protocol, and train site staff accordingly. I also collaborate with data management in resolving queries and identify potential risks and proactively take action to prevent and mitigate them.
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