You conduct site qualification, initiation, monitoring, and close-out visits — both on-site and remotely
You create clear, high-quality visit reports and keep everything on track within given timelines
You stay closely connected with your study sites, ensuring continuous support and follow-up
You ensure compliance with protocols and regulations (ISO 14155, GCP, EU MDR, FDA, etc.)
Most importantly, you safeguard the rights, safety, and well-being of study participants
Ensure data quality you can trust
You support submissions to Ethics Committees and competent authorities
You review and verify clinical data against source documentation, ensuring accuracy and completeness
You monitor informed consent processes and documentation
You ensure timely and accurate entry of data in EDC systems
You identify, document and follow-up on data queries, deviations, and open action items
Drive quality & compliance excellence
You keep Trial Master Files and site documentation audit-ready at all times
You identify and report protocol deviations, adverse events, and other critical findings in accordance with regulatory and internal requirements
You support audits and inspections with confidence
You assist with contracts, invoices, and other study related financial aspects
You follow — and help strengthen — SOPs and quality standards
Build strong site relationships
You act as a trusted partner to investigators and site staff
You train and guide sites on protocols, devices, and procedures
You create a positive, collaborative study environment
YOUR PROFILE
You have a degree in Life Sciences, Nursing, Biomedical Engineering, or a related field — or an equivalent combination of education and hands-on clinical research experience
You’ve gained 2–3+ years of experience in clinical research, including working as a CRA — ideally within medical device studies
You’re confident conducting site initiation, monitoring, and close-out visits in the DACH region (on-site and/or remote)
You’ve worked with Ethics Committees and Competent Authorities and understand their expectations
You have solid knowledge of GCP (ISO 14155) and EU MDR (2017/745); familiarity with FDA regulations (21 CFR) is a plus
You communicate fluently in English and German; any additional European language is a bonus
You’re open to travel (typically 30–70%) and enjoy being close to your study sites
You work independently, stay organized, and can manage multiple sites or studies at once
You have a strong attention to detail and a solution-oriented mindset
You’re proactive, collaborative, and enjoy working with different stakeholders
You manage your time effectively and stay on top of competing priorities
You’re comfortable working with EDC systems and MS Office tools
WE OFFER
Be part of an international and dynamic team where collaboration and a hands-on mentality drive daily work
A flexible working environment that supports a healthy work-life balance e.g. this role can be on-site in our Bochum office, hybrid or remote
Benefit from a comprehensive onboarding program to help you quickly feel at home and succeed in your role
Grow with us - we offer the possibility to evolve within the team and take on new responsibilities
A fair and motivating remuneration system that values your contribution
Attractive benefits such as a company pension scheme (bAV) and capital-forming benefits (VWL)
Celebrate successes together at regular company and team events
JobRad as a sustainable alternative for your commute to work and in your free time
About us
phenox GmbH is a specialized manufacturer of Class III medical devices for the treatment of neurovascular diseases, which are developed, manufactured and distributed. Our innovative technologies and solutions are used by neuroradiologists worldwide to treat strokes and aneurysms. We offer a growing portfolio of innovative treatment options - including long-established technologies.
