Clinical Research Associate

Nbcd A/S; Denmark; Teletrabalho; DKK 600 000 - 800 000; Tempo integral

Resumo da oferta

NBCD, a Sanos Group CRO, seeks a Clinical Research Associate to perform on-site monitoring across Denmark and international sites. You will ensure patient safety, data integrity, and regulatory compliance while communicating in English and Danish.

The role offers growth within a world-leading organization devoted to musculoskeletal disease trials. Based in Søborg, you will work with Clinical Trial Managers and participate in centralized monitoring initiatives, with travel to sites in Denmark and

Qualificações

• Degree in health sciences with GCP/trials experience.
• Strong command of English for professional communication.
• Danish language skills are highly preferred for Danish sites.

Responsabilidades

• Conduct on-site monitoring of NBCD trials per ICH-GCP with regular visits to sites in Denmark and abroad.
• Protect patient rights and ensure trials are conducted per protocol and GCP.
• Verify accuracy and completeness of data against source documents.
• Educate site staff and provide guidance on study-related matters.
• Write visit reports and investigator correspondence.
• Participate in Centralized Monitoring and remote data review from Søborg.
• Collaborate with CTMs and assist with study or vendor management tasks.

Conhecimentos

On-site monitoring

ICH-GCP knowledge

Business English

Danish language

Formação académica

Bachelor's degree in health sciences

Descrição da oferta de emprego

Are you passionate about clinical research and eager to make a significant impact in the world of drug development? NBCD is seeking a dedicated Clinical Research Associate (CRA) to join our dynamic team at the forefront of international drug development research. Join us in an environment fueled by dedication and inspired by our core values: "Team up, Take on, and Try out." Here, you’ll have the chance to make a significant difference while expanding your skillset.

Who are we?

NBCD, a key part of the Sanos Group with around 245 employees, is a world-leading CRO specializing in osteoarthritis and musculoskeletal diseases. We provide top-tier scientific and clinical trial services to the biotech and pharmaceutical industries. At NBCD, innovation is at our core, enabling us to develop life-changing medications efficiently through pioneering study designs and flawless execution. We focus on a few therapeutic areas, letting science drive our business, particularly in connective tissue diseases like osteoarthritis and rheumatoid arthritis. Our comprehensive support covers everything from study design to regulatory affairs, ensuring expert handling at every step. Renowned worldwide for our scientific and operational excellence, NBCD leads in international medication development.

Your key role and responsibilities

Your role will be highly varied and include the following responsibilities:

• You will conduct on-site monitoring of NBCD trials according to ICH-GCP, which involves regular visits to hospitals and clinics in Denmark and other countries to:
• Ensure patient rights and safety are protected, and that physicians conduct trials according to protocols, Good Clinical Practice (GCP), and approved procedures.
• Verify that electronically reported data is accurate, complete, and matches source data in patient files.
• Educate site staff and provide guidance on study-related matters.
• Write visit reports and follow-up letters to investigators.

NBCD has pioneered Risk-Based Monitoring, and you will play a critical role in Centralized Monitoring, a major part of this process. This includes:

• Remotely reviewing clinical database entries at our Søborg office to ensure data quality by proactively identifying issues, analyzing trends, and querying investigators for appropriate actions.
• Documenting findings and actions in centralized monitoring reports.
• Ensuring the Centralized Monitoring approach effectively identifies issues remotely.

Additionally, you will have the opportunity to work closely with our Clinical Trial Managers (CTM), assist them and gain responsibility for various tasks related to study or vendor management. These tasks can be tailored to your skills and interests.

Desired skills and experience

We are looking for candidates with an educational degree in health sciences who have experience with good clinical practice and clinical trials, whether through university projects or previous positions. Excellent communication skills are essential, and since most of our communication is in English, fluency in business English, both oral and written, is required.
Additionally, as the role involves on-site monitoring at Danish investigational sites, we prefer candidates who speak Danish natively or fluently.

Personal profile

You excel at working independently and take full accountability for your responsibilities. With a keen eye for detail, you understand that study monitoring relies on the accurate and thorough review of patient files and supporting documents. You are dedicated to meeting deadlines and following through on commitments, working persistently and with self-motivation.

You are committed to fostering a positive work environment where colleagues can thrive. You approach challenges with a solution-oriented mindset, maintaining a positive and optimistic outlook that encourages collaboration and respects individualism.

You are comfortable with broad responsibilities, as we value agility and efficiency, and believe in empowering our employees with the freedom to operate and innovate.

Your enthusiasm for innovative research drives your desire to learn new approaches and expand your core skill set.

Additionally, you are willing and able to travel both within Denmark and internationally, as our CRAs also monitor sites in English-speaking countries such as the UK and USA.

Are we the right cultural fit for you?

Our commitment to you is encapsulated in our promise to every one of our employees saying ‘Trust in you - in your development and impact´.

This pledge extends uniformly across all entities within the Sanos Group organization, including NBCD, ensuring that you feel its effects from the very offset of your interaction.

If you are curious about whether you would thrive within the Sanos Group culture and the Sanos Way of Leading, reflect on whether you see yourself working within our principles:

• Take on -Responsibility is given, and we inspire you to take it.
• Try out -Explore diverse tasks and grow professionally.
• Team up -We don’t just work together; we thrive together.

Want to know more? Check out the Voice of NBCD people here .

Apply and make a real impact

For further information about the role please contact, AssociateDirector,AnneAndresen,[e-mail].

You will be office-based at our headquarters in Søborg and you will be required to travel on a regular basis to our clinical sites within Denmark and other countries.

If you proceed in the recruitment process, you will go through a few additional steps where both you and we will assess whether this position is the right match for both parties. As part of the recruitment process, we use assessments to ensure the optimal match and the best foundation for future collaboration.

NBCD is dedicated to fostering a diverse and inclusive workplace. We believe that a variety of perspectives leads to better decision-making and innovation. We welcome applicants from all backgrounds and are committed to creating an environment where everyone can thrive.

We value your data and take care to protect it. Please see more information regarding privacy for job applicants here: https://nbcd.career.emply.com/privacy-policy.

Asger Bering Kristensen Managing Director, NBCD & Integrated Solutions

Position type: Full time