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

Bochum, Bavaria, Germany -

Full Time

Start Date

Immediate

Expiry Date

05 Aug, 26

Salary

0.0

Posted On

07 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Study Monitoring, Site Qualification, GCP, ISO 14155, EU MDR, FDA Regulations, EDC Systems, Trial Master File Management, Clinical Data Verification, Informed Consent Monitoring, English Fluency, German Fluency, Site Relationship Management, Audit Readiness, Protocol Compliance, Medical Device Research

Industry

Medical Equipment Manufacturing

Description

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 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.

Responsibilities

The CRA is responsible for conducting site qualification, initiation, monitoring, and close-out visits to ensure compliance with protocols and regulations. They must safeguard participant safety, ensure high data quality in EDC systems, and maintain audit-ready Trial Master Files.