Open Position: Project Manager + Clinical Research Associate, full-time
The Clinical Center for Studies in Regenerative Medicine (CCSRM) at the Ludwig Boltzmann Institute for Traumatology, the Research Center in Cooperation with AUVA, is looking for a committed new team member to support the organisation, planning, and execution of clinical trials (in accordance with the Medicinal Products Act and Medical Devices Act). We are hiring for a combined position as Project Manager and Clinical Research Associate, to start as soon as possible.
Location: Vienna
Scope: 40 h/week, permanent position
Your responsibilities
- Planning, coordination, and execution of investigator-initiated clinical studies in accordance with the Medicines Act and Medical Devices Act
- Supporting and advising LBI Trauma research groups regarding the clinical feasibility of preclinical results
- Drafting study protocols, patient information and informed consent documents as well as other study-related documentation in accordance with international guidelines
- Preparing and managing Investigator Site Files (ISF) and Trial Master Files (TMF), including document management
- Conducting on-site monitoring
- Preparing monitoring visit reports and close-out reports
- Notification of clinical trials to CTIS, ethics committees, authorities and insurance companies.
- Registration of trials on clinicaltrials.gov
- Managing contracts and coordination with participating partners and funding agencies
- Preparing study budgets and cost estimates
- Independently managing a study site as clinical monitor
- Serving as point of contact for sponsors, study sites, and regulatory authorities
- Supporting recruitment of investigators and selection of study centres
- Assisting with data and quality management
Your profile
- Completed degree in a life sciences field or a qualification in a health profession (e.g. registered nurse, biomedical analyst)
- Minimum of 3 years of experience in clinical trials
- Solid understanding of Good Clinical Practice (ICH GCP), Clinical Trials Regulation (CTR), and Medical Device Regulation (MDR)
- Training as a clinical monitor is a plus
- Independent, detail-oriented, and reliable work style
- Excellent German and English skills, both written and spoken
- Proficient in MS Office
- Team-oriented, open-minded, and willing to work in a creative, international environment
- Willingness to travel within Austria
What we offer
- A collaborative and respectful working atmosphere in an interdisciplinary team
- A dynamic and varied field of work
- Opportunities for personal and professional development
- High degree of autonomy and responsibility
- Flexible working hours and work-from-home options
- Permanent contract after a one-month probation period
If all criteria are met, the starting gross salary for this position is € 3,994.63.
Interested?We look forward to receiving your application, including your resume!
Contact: bssvpr@genhzn.yot.np.ng
Subject line: CCSRM_ Application
Application deadline: 15.07.2025