Job Description

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Clinical Research Associate

Category: Clinical Development and Medical

Location:

Bangalore, Karnataka, IN

Clinical Research Associate (CRA)

Location- Bangalore

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, 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.

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

Quality responsible person at the site

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.

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 commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize 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 communities we operate in. Together, we\'re life changing.

Contact

To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions).

Novo Nordisk