Clinical Research Associate
4 days ago
Company Description
BiTrial is a leading Contract Research Organization (CRO) in the Central and Eastern Europe Region, with operations in Hungary, Romania, Slovakia, Austria, Poland, the Czech Republic, Slovenia, Croatia, Bosnia and Herzegovina, Serbia, North Macedonia, Montenegro, Bulgaria, Moldova, Georgia, Armenia, and Azerbaijan. Since 2002, BiTrial has been providing comprehensive clinical trial services for CROs, Pharma and Biotech companies, as well as Medical Device and In-vitro Device manufacturers. With over two decades of experience, BiTrial excels in managing clinical trials across various therapeutic areas including oncology, respiratory diseases, rheumatology, neurology, hematology, immunology, cardiology, pediatrics, and general medicine. Our commitment to patient-centricity and advanced solutions significantly reduces the time required for drug and medical device development.
Role Description
This is a full-time office based role for a Clinical Research Associate. As a Clinical Research Associate you will have the unique opportunity to have an exciting career in the field of drug and medical device development as part of an expanding team.
The Clinical Research Associate will be responsible for monitoring clinical trials, ensuring regulatory compliance, collecting and organizing data, and communicating with clinical sites. Duties also include preparing trial-related documentation, managing study timelines, and ensuring the accuracy and integrity of data. The role requires collaboration with multiple stakeholders, including sponsors and healthcare professionals, to ensure the successful execution of clinical trials.
Responsibilities:
- Conduct different types of monitoring visits (pre-study visits, site initiation visits, interim monitoring visits & close out visits)
- Develop and maintain site and investigator relationships to ensure clinical trials are managed efficiently
- Perform source document verification and prepare monitoring visit reports, including confirmation and follow-up letter
- Manage the study documentation and other essential trial related documents
- Support regulatory submissions to the Competent Authority
- Participate in Investigator selection/feasibility process
Your profile:
- University degree in health or natural science related field
- CRA experience is an advantage
- Excellent verbal and written communication skills in English and Hungarian
- Valid driving license
- Demonstrated flexibility in schedule and willingness to travel on a regular basis
- Ability to respond quickly to changing demands and opportunities
- Detail-oriented and efficient in time management
- Advanced skills and experience using Microsoft Office (Word, Excel, Power Point, Outlook)
We are looking forward to receiving your application with your professional CV in English
At BiTrial, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. BiTrial is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment.
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