Auf einen Blick
- Aufgaben: Überwache klinische Studien und arbeite an bahnbrechenden Therapien für seltene Krankheiten.
- Unternehmen: Führendes globales Unternehmen in der klinischen Forschung mit innovativen Partnern.
- Vorteile: Wettbewerbsfähiges Gehalt, Firmenwagen, flexible Arbeitszeiten und berufliche Weiterentwicklung.
- Weitere Informationen: Reisebereitschaft von 60-70% durch Deutschland und Europa.
- Warum dieser Job: Gestalte die Zukunft der Medizin und mache einen echten Unterschied im Leben von Patienten.
- Qualifikationen: Abschluss in Lebenswissenschaften und Erfahrung in der klinischen Forschung.
Das prognostizierte Gehalt liegt zwischen 59400 - 72600 € pro Jahr.
- Clinical Research Associate II / Senior Clinical Research Associate
- Rare Diseases | Cell & Gene Therapy
- Travel: Approximately 60–70% across Germany and selected European sites
- About the Opportunity
Our client is a leading global Clinical Research Organisation partnering with innovative biotechnology and pharmaceutical companies to deliver pioneering therapies for patients with rare and orphan diseases.
As their portfolio continues to grow, they are seeking an experienced Clinical Research Associate to join their German clinical operations team.
This position offers the opportunity to work on cutting-edge Cell & Gene Therapy programmes, supporting first-in-human through late-phase clinical studies that have the potential to transform patients' lives.
This is an excellent opportunity for an ambitious CRA who enjoys working in complex therapeutic areas, building strong investigator relationships and contributing to studies where every patient truly matters.
The Role
As a Clinical Research Associate, you will be responsible for overseeing the successful delivery of clinical trials across Germany, ensuring studies are conducted in accordance with ICH-GCP, local regulatory requirements and sponsor expectations.
You will work closely with investigators, study coordinators, project management teams and sponsors to maintain the highest standards of patient safety, data integrity and protocol compliance.
Key Responsibilities
- Perform site qualification, initiation, routine monitoring and close-out visits.
- Ensure studies are conducted in accordance with ICH-GCP, protocol requirements and applicable regulations.
- Build strong relationships with Principal Investigators and study site personnel.
- Monitor patient safety, protocol compliance and data quality throughout the study lifecycle.
- Review source documentation and verify clinical data within EDC systems.
- Support site staff with protocol training and study procedures.
- Identify and proactively resolve site issues, escalating risks where appropriate.
- Collaborate with Clinical Trial Managers and cross-functional study teams.
- Ensure timely collection of essential documents and maintenance of Trial Master File documentation.
- Contribute to inspection readiness and support sponsor and regulatory audits.
About You
We're looking for someone who enjoys working in highly specialised clinical research and thrives in collaborative, science-driven environments.
You will ideally have
- A Bachelor's degree in Life Sciences, Pharmacy, Nursing or a related discipline.
- Previous independent monitoring experience as a CRA within a CRO or pharmaceutical company.
- Strong knowledge of ICH-GCP and European clinical trial regulations.
- Experience monitoring Phase I–IV clinical studies.
- Excellent communication and stakeholder management skills.
- Fluency in both German and English.
- Willingness to travel extensively across Germany.
Desirable Experience
- Experience in one or more of the following areas would be highly advantageous:
- Rare and orphan diseases
- Cell & Gene Therapy
- Oncology
- Haematology
- Advanced Therapy Medicinal Products (ATMPs)
- Early Phase clinical trials
- Complex biologics or precision medicine programmes
- What You'll Receive
- Competitive base salary with annual performance bonus.
- Company car or car allowance.
- Comprehensive benefits package.
- Flexible home-based working.
- Ongoing professional development and career progression.
- Exposure to some of the most innovative Cell & Gene Therapy programmes currently in development.
- Opportunity to work alongside internationally recognised sponsors developing life-changing treatments for patients with significant unmet medical needs.
Clinical Research Associate Arbeitgeber: Barrington James
Als führendes globales Pharmaunternehmen bieten wir Ihnen die Möglichkeit, eine Schlüsselrolle in der neu geschaffenen Funktion der analytischen Entwicklung zu übernehmen. Unser dynamisches Arbeitsumfeld fördert Innovation und Zusammenarbeit, während wir Ihnen umfangreiche Möglichkeiten zur beruflichen Weiterentwicklung und Mentoring bieten. Mit einem starken Fokus auf Compliance und Qualität unterstützen wir Sie dabei, Ihre Karriere in der Frankfurter Region voranzutreiben und einen bedeutenden Beitrag zur Entwicklung neuer Medikamente zu leisten.
