Clinical Research Associate

**Clinical Research Associate**

**Bangalore**

Job Ad for WISE (Women Inclusion Strengthening Excellence)

The Novo Nordisk WISE program is an opportunity for women who have taken a career break for a minimum of a year or

more and are ready to return to work. We are offering full-time paid roles for experienced professionals in various domains.

Relaunch your career with us and be part of aspirational projects and challenging assignments at Novo Nordisk. We are highly committed to hiring diverse talent and your unique journey and skills are acknowledged and appreciated by us.

WISE Program would include:

- Comprehensive onboarding and domain specific skills training
- Hand holding for smooth integration into the role by assigned mentors
- Dedicated projects assigned to you for effective on-the-job learning
- Access to resources that would help you in enhancing your knowledge and skills
- A full-time role after the completion of the program

A pause in your career should not define it. Let us help you kickstart your journey to a life-changing career with Novo Nordisk.

**Clinical Research Associate**

**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 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

**Additional responsibilities**:

- Timeliness in deliveries through process planning and goal setting
- Identify potential risks and proactively take action to prevent and as needed, mitigate
- 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.

**Education requirements**
- Graduate in Medicine, Science, Pharmacy or other relevant
- ICH GCP trained and if applicable certified
- Additional qualification on clinical research would be preferred.

**Work experience**
- 2 - 4 years of experience as a CRA
- Experience in 1-2 multinational clinical trials phase 2-3 from site initiation till site closure

**About the department**

Novo Nordisk is a Denmark based multinational with leadership in diabetes. Novo Nordisk India affiliate office is located in Bangalore & has more than 1400 people working across the country in various functions.

**Working at Novo Nordisk**

At Novo Nordisk we recognise that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and the communities we operate in.

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