Clinical Research Associate - Denmark
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Posted on : 09 June 2017
Clinical Research Associate (CRA)
- Our company is an international drug development organization. We believe that personalized medicine and innovation in study design and execution is the key to developing new drugs smarter, better and faster.
- Our company was established in 2006 and is a division of the company established in 1992.
- Our company provides scientific and clinical trial services to the biotech and pharmaceutical industry in addition to developing own drug candidates.
- Our company currently consists of 20 employees based in Denmark and 6 Clinical Research Associate’s based throughout Europe and Asia.
- We perform all aspects of pre-market clinical trials such as data management, regulatory affairs, pharmacovigilance, monitoring and trial management.
- We are a niche Clinical Research Organization (CRO) specialized in clinical drug development of personalized medicine based on our proprietary biomarker-technology.
- We focus our efforts on innovative clinical trials in few therapeutic areas, where we can provide particular additional value such as osteoarthritis, rheumatoid arthritis, osteoporosis and diabetes.
- Our company is a small, but growing operation, which means we rely on, and leverage our agility and efficiency.
- Every team member has broad responsibilities and we strongly believe in empowerment and giving our employees freedom to operate and to innovate.
- As a result of our continued growth, we are now looking for a person to be a part of our CRA team.
- Your job as Clinical Research Associate is highly varied and will amongst other responsibilities include the following:
- You will act as liaison between the sponsor and the investigator and play a very important role in motivation of the investigators at the clinics and in ensuring patient safety and data integrity.
- You will perform on-site monitoring of the trials performed by our company 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 and approved procedures
- Verify and ensure that the 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
- Centralized monitoring (Risk Based Monitoring) of the trial, which includes:
- Reviewing data at the office 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.
- Assist Clinical Trial Managers in ad hoc study management related tasks, which will be tailored to your wishes and your skills (or desired skills).
Desired skills and experience
- You have an educational degree within health sciences
- You have experience with GCP 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.
- 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 for shorter periods. Our CRA’s are also actively monitoring English-speaking countries such as UK, USA and Hong Kong.
we are offering
- An important role in a highly dynamic research-organization with world-wide reach
- An environment driven by science and good ideas, where you can truly make a difference and see your own ideas come to life
- Great opportunities for personal development
- The possibilities to broaden your efforts, being introduced to all clinical and non-clinical pre-market aspects of drug development in one place
- Voluntary contribution to our academic publication activities: Our company publishes around 40 peer-reviewed articles each year
- A flat, tight organization in which your successes will not go unnoticed