Clinical Trial Source Specialist
700,000 Ft / monthBrutto
Employer · Óbudai Egészségügyi Centrum Kft.
Medical records technician
Other health professional
Administrative assistantFull-timeTemporaryBudapest
An exciting opportunity as arisen for a Clinical Trial Source Specialist to join the team on a 12 Month Fixed Term Contract! The Clinical Trial Source Specialist plays an important role in the development, organisation, quality control, and maintenance of both paper and electronic source documentation for clinical trials.
Tasks
- Support the Clinical Trial Source Lead in the creation, development, and maintenance of study source documentation, including paper and electronic source.
- Support the formal finalisation, document control, and version management of study documentation, including Source Planning Lists (SPLs), trackers, and related materials.
- Conduct quality control checks of study source documentation to ensure accuracy, consistency, and compliance.
- Support the review of study protocols and related documents to identify study source data collection requirements.
- Support the Principal Clinical Trial Source Specialist and/or Project Manager with study set-up within the CTMS platform, where required.
- Work closely with the Site Readiness team to obtain appropriate review and input into source design and build.
- Coordinate with project teams to ensure study source documentation and study builds are delivered in line with agreed timelines.
- Attend relevant study meetings, including Clinical Study Team (CST) meetings and eSource review meetings.
- Contribute to the continuous improvement of source documentation processes and study set-up activities.
Requirements
- Previous experience working within a clinical research environment.
- Strong organisational and planning skills, with the ability to manage multiple priorities and deadlines.
- Excellent attention to detail and a commitment to delivering accurate, high-quality work.
- Proficiency in Microsoft Office applications, particularly Word, and Adobe Acrobat.
- Familiarity with clinical trial systems such as CTMS, EDC, or eSource platforms is desirable.
- Knowledge and understanding of clinical research processes, including ICH-GCP and relevant regulatory requirements.
- The ability to interpret clinical trial protocols and translate protocol requirements into appropriate source documentation and study design.
- Strong communication and interpersonal skills.