Clinical Research Associate (CRA) for NBCD A/S - a Science-Driven Drug Development Organization
You will serve as the primary contact with the clinical sites that you act as responsible CRA for. You will act as liaison between the sponsor and the investigational site and play a very important role in motivation of the investigators to reach their enrollment targets at the clinics and in ensuring patient safety and data integrity. As a CRA you will be working closely with our Clinical Trial Managers (CTM) in ad hoc study management related tasks.
NBCD A/S is an international drug development organization. We believe that innovative study designs and execution are key aspects in developing new drugs smarter, better, and faster.
We provide biotech and pharmaceutical industry with scientific and clinical trial services to in addition to developing in-house drug candidates.
NBCD perform all aspects of clinical trials including trail design, protocol writing, medical monitoring, data management, regulatory affairs, pharmacovigilance, and trial management.
We focus our efforts on innovative clinical trials in few therapeutic areas, so that we can provide additional value based on our research-legacy in connective tissue-diseases such as osteoarthritis and rheumatoid arthritis. We operate at the forefront of international drug development research and are internationally renowned for scientific and operational expertise.
NBCD is a part of the Sanos Group, consisting of independent business units encompassing Sanos Clinic, Sanos Supply and Studies&Me.
At present the Group includes around 100 employees – and growing consistently.
All business units in the Sanos Group are dedicated to providing first-class clinical research, aiming to keep improving and develop how we conduct innovative clinical trials.
As our organization is growing, we are now looking for our new colleague.
About the job
Your job as Clinical Research Associate is highly varied and will amongst other responsibilities include the following:
You will perform on-site monitoring of the trials performed by NBCD according to ICH-GCP. This involves visiting hospitals and clinics in Denmark and other countries on a regular basis to:
- Verify that the patients’ rights and safety are protected and that the physicians are conducting our trials according to the protocol, Good Clinical Practice (GCP) and approved procedures
- Verify and ensure that the electronically reported data from the trial is accurate, complete and matches the source data in the patient files.
- Educate site staff and provide guidance on study related matters
- Write visit reports and follow up letters to the investigators
You will be office-based at our Headquarters in Herlev and you will be required to travel on a regular basis to our clinical sites within Denmark and other countries.
NBCD has pioneered Risk-Based Monitoring and you will be a critical player in performing Centralized Monitoring of the trial, which is a major part of our Risk-Based Monitoring process, this includes:
- Remotely reviewing data entered in the clinical database at the office in Herlev to ensure good data quality by identifying issues proactively and by analyzing trends and to query the investigators to take appropriate action.
- Document findings and actions in centralized monitoring reports.
- Ensure that the Centralized Monitoring approach is effective in discovering issues that can be identified remotely.
Furthermore, you will have the opportunity of working closely with our Clinical Trial Managers (CTM), being an assisting CTM, gaining responsibility for different tasks related to study or vendor management and these tasks can be tailored to your wishes and your skills (or desired skills).
Advantages of working with NBCD
You will play an important role in a highly dynamic research-organization with world-wide reach in an environment driven by science and good ideas, where you can truly make a difference and see your own ideas come to life.
It is possible for you to broaden your skillset, being introduced to all clinical and all clinical and non-clinical pre-market aspects of drug development in one place.
We invest in developing and promoting our staff and you will be given great opportunities for personal and professional development – we are a flat, tight organization in which your successes will not go unnoticed.
You get the opportunity to contribute to our academic publication activities and authoring impactful new papers - NBCD publishes several peer-reviewed articles each year in highly regarded medical journals.
Desired skills and experience
- You have an educational degree within health sciences
- You have experience with Good Clinical Practice and Clinical Trials from either university projects or previously held/current positions
- You are a responsible person who can work independently and assume accountability of your delegated responsibilities.
- You have a good eye for details, as study monitoring relies on accurate and thorough review of patient files and supporting documents.
- You are solution-oriented and see possibilities rather than problems.
- You thrive with broad responsibilities – as we rely on our agility and efficiency. We strongly believe in empowerment and giving our employees freedom to operate and to innovate.
- We expect you to be enthusiastic about innovative research and desire to learn new approaches and expand your core skill set.
- You must have excellent communications skills and, as most our communication is in English, you must be fluent in business English (oral and written).
- As you will be performing on-site monitoring on Danish investigational sites, we would prefer if you speak Danish as a native or at least fluently.
- Ability and willingness to travel inside and outside Denmark. Our CRA’s are also actively monitoring English-speaking countries such as UK and USA.
Do you want to join us?
To apply please send your CV and a letter of motivation to firstname.lastname@example.org - we are looking forward to hearing from you!
For further information about the role contact Kalliroi Konstantinidou, Associate Director of Clinical Operations, at email@example.com. We are conducting interviews on a regular basis and will close the position when we find the right candidate.
We can use assessments as a part of the recruitment process.
We encourage all qualified candidates to apply for the position – regardless of ethnic background, gender, sexual orientation, disability, religion or age.
We value your data and take care to protect it. Please see more information regarding privacy for job applicants here.
Work location: Herlev Hovedgade 82, 2730 Herlev.
At NBCD we focus our efforts on innovative clinical trials in few therapeutic areas, where we can provide additional value with our scientific expertise addressing unmet medical needs.
As a part of the Sanos Group you will join a global company – dedicated to providing first-class clinical research.