Clinical Research Associate

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

Job summary

Astrum CRO is seeking a Clinical Research Associate to plan, execute and monitor clinical trials from site initiation through close-out in Munich. You will ensure regulatory compliance, ICH-GCP and study protocol adherence, while prioritising patient safety and data integrity.

As the primary link between Project Managers, study sites and sponsors, you will support site feasibility, monitoring visits, data queries and regulatory documentation, with opportunities to advance within our structured

Qualifications

• Degree in Life Sciences, Nursing, Pharmacy or related field; equivalent experience may be considered.
• Familiarity with clinical trial systems (EDC, CTMS, eTMF) and MS Office.
• Strong communication, organisational and problem-solving skills.
• Ability to work independently and as part of a team.
• Fluency in English (spoken and written); other languages are a plus.

Responsibilities

• Plan, execute and monitor clinical trials from site initiation to close-out.
• Ensure regulatory compliance (ICH-GCP) and adherence to study protocols.
• Manage site feasibility, selection and ongoing site management activities.
• Review CRFs, source documents and regulatory binders for accuracy.
• Identify and document protocol deviations and implement CAPAs.
• Support participant recruitment, screening and retention.
• Monitor safety and report SAEs timely and accurately.
• Conduct on-site and remote monitoring visits per monitoring plan.
• Resolve data queries and assist with regulatory submissions and eTMF filing.
• Train site personnel on protocol requirements and safety procedures.

Skills

Communication

Organizational skills

Problem-solving

Teamwork

Education

Bachelor's degree in Life Sciences or related field

Equivalent experience in clinical research

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.

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.