Clinical Research Associate - Central or East regions Germany

Astrum; Ismaning; On-site; EUR 48,000 - 72,000; Full time

Job summary

Astrum in Germany is seeking a Clinical Research Associate to plan, execute and monitor clinical trials from site initiation through close-out, ensuring regulatory compliance, ICH-GCP and study protocols while prioritising patient safety and data integrity.

You will act as the primary link between the Project Manager, study sites and sponsor, supporting site feasibility, monitoring visits, data management and regulatory submissions within our Professional Career Framework.

Qualifications

• Degree in Life Sciences, Nursing, Pharmacy or related field.
• Experience in clinical research including regulatory compliance.
• Fluency in English; additional languages are an advantage.
• Strong communication, organisational and problem‑solving skills.

Responsibilities

• Assess potential sites for feasibility and selection based on capabilities and recruitment potential.
• Ensure studies comply with protocol, ICH-GCP, regulations and company policies; maintain accurate trial documentation.
• Conduct on-site and remote monitoring visits per monitoring plan; apply risk-based monitoring.
• Resolve data queries with site staff; support regulatory submissions and eTMF filing.
• Train site personnel on protocol, compliance and safety; liaise with project managers and investigators.

Skills

Communication skills

Organisational skills

Problem solving

English fluency

Teamwork

Microsoft Office

Education

Degree in Life Sciences, Nursing or Pharmacy

Tools

EDC

CTMS

eTMF

Microsoft Office

Job description

We are looking for a Clinical Research Associate to plan, execute and monitor clinical trials from site initiation through close-out. You will ensure compliance with regulatory requirements, ICH-GCP and study protocols, while prioritising patient safety, data integrity and timelines. As the primary link between the Project Manager, study sites and sponsor, you will have the opportunity to grow within our structured Professional Career Framework.

Key Responsibilities

Site Feasibility & Selection

• Assess potential sites based on their capabilities, recruitment potential, staff experience and overall suitability.

Site Management

• Ensure studies are conducted in accordance with the protocol, ICH-GCP, applicable regulations and company policies.
• Verify that CRFs, source documents and regulatory binders are accurate, complete and up to date.
• Identify, document and report protocol deviations, and ensure appropriate corrective and preventive actions are implemented.
• Support participant recruitment and retention through effective screening and eligibility processes.
• Monitor patient safety and ensure the timely and accurate reporting of Serious Adverse Events (SAEs).
• Lead close-out activities, confirming the completeness of study data and documentation.

Monitoring

• Conduct on-site and remote monitoring visits—including pre-study, initiation, routine, accompanied and close-out visits—in accordance with the monitoring plan.
• Apply Risk-Based Monitoring principles to focus oversight on areas with the greatest potential impact on patient safety and data integrity.

Data Quality & Documentation

• Resolve data queries in collaboration with site staff and Data Management.
• Review and collect essential documents, support regulatory submissions and ensure accurate (e)TMF filing in collaboration with the Clinical Trial Administrator.

Training & Collaboration

• Train site personnel on the protocol, compliance requirements and safety procedures.
• Act as the primary point of contact for study sites, working closely with Project Managers and investigators to keep trials on track.

Requirements

• Degree in Life Sciences, Nursing, Pharmacy or a related field; equivalent experience in clinical research may also be considered.
• Familiarity with clinical trial systems, including EDC, CTMS and eTMF, as well as proficiency in Microsoft Office.
• Strong communication, organisational and problem‑solving skills.
• Ability to work independently and effectively as part of a team.
• Fluency in spoken and written English; additional languages are an advantage.