Senior Clinical Research Associate - FS

Premier Research Group; Deutschland; Presencial; EUR 70 000 - 90 000; Tempo integral

Resumo da oferta

Premier Research Group sucht einen Senior Clinical Research Associate - FS zur Verstärkung des Functional Services Provider-Teams. Sie unterstützen Biotech-/Medtech-/Pharma-Kunden bei der Umsetzung von Studien und arbeiten eng mit standortübergreifenden Teams zusammen.

Zu den Aufgaben gehören Quellüberprüfung, Dokumentation, Schulung des Studienpersonals, Unterstützung bei Inspektionen und Verwaltung von Verträgen sowie Einreichung relevanter Unterlagen.

Qualificações

• Bachelor’s degree in a clinical/biological/scientific/health-related field or equivalent.
• Senior CRA with 5–7 years' on-site monitoring and site management experience.
• Fluent in German and English (written and spoken).

Responsabilidades

• Conduct source verification by comparing CRFs to source documents and verify informed consent forms.
• Maintain thorough visit reports and escalate issues as needed.
• Ensure site personnel are trained and prepared per protocol and regulations.
• Support regulatory inspections as required.
• Identify and document reportable events per protocol and regulations.
• Participate in study meetings, teleconferences and trainings.
• Collaborate with cross-functional teams and study sites across all phases.
• Manage study contracts and collect investigator/site documentation; review in databases.

Conhecimentos

German language fluency

English language fluency

Onsite monitoring

Formação académica

Bachelor’s degree in clinical/biological/scientific/health-related field

Ferramentas

RAVE EDC

Veeva CTMS/TMF

Descrição da oferta de emprego

Premier Research is looking for a Senior Clinical Research Associate - FS to join our Functional Services Provider (FSP) team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
• Your ideas influence the way we work, and your voice matters here.
• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What You’ll Be Doing

• Conducts source verification by comparing data recorded on Case Report Forms against source documents, verifying Informed Consent Forms for accuracy and completeness, and reviewing regulatory documents and device accountability records
• Maintains thorough documentation and proper escalation of issues related to visit reports.
• Ensures all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with the protocol and applicable regulations.
• Supports regulatory inspection activities as required.
• Ensures that all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations.
• Participates in study-specific meetings, teleconferences and trainings.
• Collaborates with cross-functional team members and study sites throughout all study phases.
• Manages study contracts, requests/collects relevant investigator/site documentation (i.e. regulatory documents, financial disclosure forms, curriculum vitae/medical license), and reviews and approves documents in applicable database.

What We Are Looking For

• Bachelor’s degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field or equivalent combination of education, training and experience
• Senior Clinical Research Associate with 5 to 7 years of practical experience conducting continuous independent onsite monitoring of clinical research sites as well as site management activities. Must be fluent in German & English written and spoken.
• Phase I, healthy human volunteers is preferred; however, we can look at candidates who have strong Oncology experience. Experience monitoring PK samples and process on-site, along with, safety assessments recommended.
• RAVE EDC and Veeva CTMS/TMF very nice to have
• To start mid Jan-2027 and end at the end of the year.