Clinical Research Associate - Central or East regions Germany

ASTRUM; München; Presencial; EUR 52.000 - 75.000; Jornada completa

Descripción de la vacante

Astrum CRO is seeking a Clinical Research Associate for Central or East Germany to plan, execute, and monitor clinical trials from site initiation through close-out. You will ensure regulatory compliance, data integrity, and patient safety while coordinating with project managers and sponsor teams.

Responsibilities include site feasibility, site management, monitoring visits, data quality, and training site personnel. Strong English skills and experience with EDC/CTMS/eTMF are preferred.

Formación

• Degree in Life Sciences or related field.
• Familiarity with clinical trial systems (EDC, CTMS, eTMF).
• Strong communication, organisational and problem-solving skills.
• Ability to work independently and in a team.
• Fluency in English; other languages are a plus.

Responsabilidades

• Plan, execute and monitor clinical trials from site initiation through close-out.
• Ensure compliance with regulatory requirements, ICH-GCP and study protocols.
• Identify, document and report deviations and implement corrective actions.
• Support participant recruitment and retention and monitor SAEs.

Conocimientos

Strong communication

Organisational skills

Problem-solving skills

Educación

Degree in Life Sciences

Equivalent experience in clinical research

Herramientas

EDC

CTMS

eTMF

Microsoft Office

Descripción del empleo

• Clinical Research Associate - Central or East regions Germany

Clinical Research Associate - Central or East regions Germany

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.