Clinical Data Coordinator, Leeds

5 months ago

Leeds, United Kingdom Fortrea Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

What if your Data Management skills are what we need to make new drugs safer for patients?

As one of the largest Clinical Research Organizations in the world, we have recently brought to life four ultramodern Clinical Research Units in the UK and USand the jewel in the crown is our facility at Drapers Yard Leeds. A brand new, world class, state-of-the-art 65,000 ft² clinic with 100 beds (and growing), fully dedicated to Phase I Clinical research (and 7 minutes walking from the train station)

And this is where you come in because we are expanding and now seeking our next Clinical Data Coordinator.
- This is a full-time, office based and permanent opportunity, working hours are 37 hours per week,
- Occasional overtime (compensated with flexi time or overtime pay.)

WHO YOU ARE
- Bring a proven track record of handling complex datasets, ideally in a clinical or scientific working environment,
- Able to demonstrate working knowledge of Microsoft Office (Outlook, Word, Excel),
- Education: A levels

Previous experience in clinical trials data management is ideal, but not a must (we´re open to explore other backgrounds, such as financial, etc.) The important thing for us is you have worked and thrive on a professional setting that is:

- Attention-to-detail focused, where accuracy in data analysis and interpretation is vital to ensure the health and safety of Phase 1 clinical trials participants,
- Fast-paced and changing priorities rapidly, where last minute deadlines are not uncommon, asking you to prioritize and adapt on the spot,
- Technology based. We are moving towards an electronic data collection & analysis environment.

Another big PLUS is if you bring experience working with Bedside Data Capture Systems.

ON A NORMAL DAY, YOU WILL

Learn. And grow. No two days will be the same; and this is because you will be exposed to a wide variety of therapies and study designs (ascending dose, first-in-human, food effect, drug to drug interactions, etc.)

But regardless of your projects, every day you will live to answer one question: “_will the new drug be safe?”_ Under this framework, you will ensure that all data and information generated in the clinic is produced on time and in accordance with the study protocol, SOPs, and in compliance with ICH/GCP. Mainly you will:

- Daily ongoing QCing and cleaning of all study data generated in the clinical floor from a variety of study teams.
- Query Resolution. Ensure all database queries; sponsor written data queries, CRA monitoring queries and internal QA audit findings are resolved within the agreed timelines.
- Ensure that the data entry and QC of dose escalation data is completed within the required timelines.
- Act as principle host for sponsor´s CRF monitoring visits. Promoting a professional image of Leeds CRU and building strong collaborative working relationships with CRA’s.

Depending on your expertise, you could also review draft protocols and support the workbook (CRF) design process.

In this job, you will witness firsthand the dosing and safety research as they are being conducted in real time. When the drug you worked with gets approved, you know you´ll touch many patient´s lives around the world.

WHERE FROM HERE?

Launch your exciting career in clinical trials This unique opportunity gives you a hands-on experience behind the scenes so you'll unlock the inner workings of the industry and gain the skills to fast-track your growth as a Clinical Research Associate or Data Manager. Join our supportive team and build a secure future in a growing field

Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our

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