Job description
Novo Nordisk has a very bright future ahead with many new innovative products in the pipeline. To reach our ambition of improving the lives of millions of people, we are now recruiting a national Clinical Research Associate (CRA) for our Clinical Research Team.
Please note, this is a UK field-based national role not eligible for relocation, reporting directly to the Clinical Research Manager in our UK affiliate.
This role covers National UK region and the location is flexible as long as you are willing to travel.
As a CRA, you will be accountable for data integrity, quality, patient safety and protection, regulatory compliance for all assigned sites, compliance to protocols, adherence to Good Clinical Practice, UK Clinical Trial Legislation, and local ethics requirements, as well as Novo Nordisk SOPs.
You will be responsible for:
- Acting as the main line of communication with Investigator site teams
- Appropriate site and investigator selection and activation, including obtaining necessary greenlight documents, training site staff, ensuring system access and conducting site initiation visits
- Conducting and documenting monitoring visits in accordance with the Monitoring Plan and Risk Indicator Reports, using risk-based quality principles
- Driving activities with sites to achieve recruitment and retention targets
- Management of protocol compliance, IMP handling and data entry requirements at site
You will demonstrate good communication skills with both internal and external stakeholders (investigators and site coordinators) for the successful implementation of your main deliverables.
Qualifications
You should have an educational background preferably within the Health Sciences (biology, pharmacy, etc.) or nursing qualification. Additional post graduate training and degrees will be considered as an asset.
The ideal candidate should have:
- Previous work experience in the same or similar positions in the pharmaceutical industry (including CROs) and Healthcare/NHS within the UK
- Knowledge of clinical trial methodology
- Knowledge of the clinical trials environment – ICH GCP, regulatory issues, sops
- Knowledge of electronic clinical trials systems – CTMS, EDC, RTSM, electronic TMF.
Preferably, you can work independently and have a good understanding of project management, as well as the ability and willingness to adjust quickly to new situations in a continuously developing environment with a service minded attitude.
About The Department
The UK Clinical Research team of approximately 100 employees is part of the UK Clinical, Medical and Regulatory (CMR) Department with responsibility for running all global development clinical trials in the UK.
You will be part of a cross functional highly motivated team responsible for the planning, execution and completion of projects related to the development of new medicinal products in a variety of therapeutic areas including diabetes, obesity, haemophilia, sickle cell disease, NASH, Alzheimer’s disease, cardiology, and growth hormone.
The scope of our activities ranges from phase I to IV clinical trials and also includes non-interventional studies, real world evidence studies and disease area studies. We have close collaborations with colleagues in our headquarters team and local stakeholders. Our environment is characterised by a global network with challenging assignments in a project centric organisation. We focus on continuous personal and professional development and exciting opportunities which arise within our international organization.
Working at Novo Nordisk
Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 50,000 employees. Together, we go further. Together, we’re life changing.
Application support
We are an equal opportunities employer, and we commit to an inclusive recruitment process and equality of opportunity for all our job applicants. If you're a person with a disability, if you're neurodivergent, and need any adjustments to be made during the application and selection process, please send an email to [email protected]. Please include your name, the role you are interested in and the type of adjustment your need.
Contact
Please apply through our careers site, we are not able to accept direct CVs.
Deadline
11th of August 2023
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.