Senior Clinical Research Associate

AL Solutions; Deutschland; Hybrid; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Competitive compensation

Benefits package

Career growth opportunities

Flexible working arrangements

Job summary

AL Solutions partners with a leading global CRO to recruit an experienced Clinical Research Associate (CRA) in Germany. The role focuses on high-quality monitoring across multiple sites with a sustainable workload of 6–8 site visits per month, ensuring adherence to ICH-GCP and German regulations.

You will oversee site qualification, initiation, monitoring, and close-out visits, manage source data and IP accountability, and collaborate with sponsor teams.

Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field.
• 3+ years independent CRA monitoring experience in Germany.
• Strong knowledge of ICH-GCP and German regulatory landscape.
• Experience across multiple therapeutic areas; Oncology or Immunology preferred.
• Fluent in German and English.
• Excellent organizational and time-management skills.

Responsibilities

• Conduct site qualification, initiation, monitoring, and close-out visits across Germany.
• Ensure sites comply with ICH-GCP and German regulatory guidelines (AMG, GCP-V) and sponsor protocols.
• Verify source data, oversee investigational product accountability, and ensure site documentation completeness.
• Identify and escalate site-level issues to support timely resolution and progress.
• Build strong relationships with site personnel and sponsor stakeholders.
• Provide training and support to site staff to ensure protocol adherence and data accuracy.
• Maintain up-to-date documentation and manage CTMS, eTMF, and EDC platforms.

Skills

Site monitoring

Site qualification & initiation

ICH-GCP knowledge

German regulatory knowledge

German & English fluency

Education

Bachelor’s degree in Life Sciences, Nursing, or Pharmacy

Tools

CTMS

eTMF

EDC

Job description

Chloe O'Shea is proud to partner with a leading global CRO delivering cutting-edge solutions in clinical development. We are seeking an experienced Clinical Research Associate (CRA) to join a dynamic and dedicated team in Germany for an exciting single-sponsor opportunity. This position offers a sustainable workload of 6–8 site visits per month, allowing you to focus on high-quality monitoring and meaningful site engagement.

The Role

As a Clinical Research Associate (CRA), you will play a critical role in overseeing the execution of clinical trials across Germany. Collaborating closely with investigative sites and sponsor teams, you will ensure compliance with study protocols, ICH-GCP standards, and German regulatory requirements. This is an ideal opportunity for professionals passionate about advancing global research within a supportive, innovation-driven environment.

Key Responsibilities

• Conduct site qualification, initiation, monitoring, and close-out visits across Germany.
• Ensure clinical trial sites operate in compliance with ICH-GCP, German regulatory guidelines (e.g. AMG, GCP-V), and sponsor protocols.
• Verify source data, oversee investigational product accountability, and ensure completeness of site documentation.
• Identify and escalat e site-level issues proactively to support timely resolution and continuous study progress.
• Build strong, collaborative relationships with site personnel and sponsor stakeholders.
• Provide training and support to site staff to ensure protocol adherence and data accuracy.
• Maintain up-to-date documentation and manage clinical systems including CTMS, eTMF, and EDC platforms.

Requirements

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field.
• Minimum of 3 years of independent monitoring experience as a CRA in Germany.
• In-depth knowledge of ICH-GCP and the German clinical regulatory landscape.
• Experience across multiple therapeutic areas, with preference for Oncology or Immunology studies.
• Fluent in German and English, both written and spoken.
• Excellent organizational, communication, and time-management skills.

What’s in It for You?

• Competitive compensation and a comprehensive benefits package.
• Opportunities for career growth within a global leader in clinical research.
• Flexible working arrangements with manageable travel expectations.
• Access to innovative technology platforms and global study networks.
• Commitment to work-life balance, mental well-being, and ongoing professional development.