Clinical Research Associate (CRA) (m/f/d), full-time

Clinical Research Associate (CRA) (m/f/d), full-time

Full-time

YOUR JOB DUTIES

Take ownership of clinical study monitoring

• 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