CRA trainee (Hungary)
Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research.
Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
We’re looking for a talented and energetic Clinical Research Associate (CRA) Trainee to join our team in Hungary! This will be a 6 month contract and will be office based in Budapest, Hungary.
This is an ideal opportunity to gain experience and training as a CRA. Ideal profiles would be study coordinators or study nurses keen to start working as a CRA. We will also consider candidates who have done a CRA course.
You'll be accountable for:
- Attending co-monitoring visits with experienced CRAs
- Communicating with the site
- Scanning documents
- Checking investigator site files
- Collecting required trial documentation
- eTMF quality control
- Assisting CRAs
You'll be trained to do the following:
- Monitoring with a focus on data integrity and patient safety
- Plans day to day activities for monitoring of a clinical study and sets priorities per site
- On-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites
- Reducing backlog and keeping it at a minimum
- Escalate issues and feedback for the team
- Provide accurate and timely submission of trip reports
- Assist project team with assessing project feasibility and recruitment
- Ensure adherence to study timeline and budget
- Participating in available training offered to increase therapeutic knowledge
You'll need this to be considered:
- Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
- Some knowledge of clinical trials is required
- Good level of English, written and verbal
- Knowledge of ICH / GCP regulations
- Excellent team player, collaborative and able to enable an effective team
- Excellent organizational and time-management skills, able to meet deadlines
- Self-starter with lots of common sense and able to act on own initiative
- Maintains a positive, results orientated work environment
- Travel: 50-70%