Clinical Research Associate

Established Search; Köln; Remote; EUR 65.000 - 85.000; Vollzeit

Zusammenfassung

A leading European Contract Research Organization is seeking a Clinical Research Associate (CRA) for remote work in Eastern Germany. The role involves monitoring clinical trial sites, ensuring compliance with regulations, and requires a strong background in Oncology trials. Candidates must be fluent in German and have significant CRA experience. This position offers flexibility and the chance to engage in impactful clinical research.

Leistungen

Flexibility and autonomy

Engagement in high-impact clinical trials

Qualifikationen

• Minimum 5 years of CRA experience, with significant exposure to Pharma-sponsored trials.
• Proven experience in Oncology trials; additional therapeutic areas are a plus.
• Experience with IVD studies is desirable.

Aufgaben

• Conduct routine monitoring visits including site initiation, interim, and close-out visits.
• Ensure compliance with ICH-GCP, German regulations, and study-specific protocols.
• Collaborate with project management, data management, and medical teams.

Kenntnisse

Fluent German

Professional English

Strong organizational skills

Communication skills

Problem-solving skills

Jobbeschreibung

Role : Clinical Research Associate (CRA)

Location : Remote, based in Eastern Germany

Languages : Fluent German and professional English required

About the Company

Our client is a well-established European Contract Research Organization (CRO) known for delivering high-quality, full-service clinical trial solutions across multiple therapeutic areas. With a strong reputation for operational excellence, sponsor collaboration, and scientific rigor, the organization partners with top-tier pharmaceutical companies and biotech firms to bring innovative therapies to patients efficiently.

They offer a supportive, science-driven culture with flexibility and autonomy, ensuring each team member plays a key role in high-impact clinical programs.

The Role

The Clinical Research Associate (CRA) will be responsible for monitoring clinical trial sites, primarily in Eastern Germany, to ensure compliance with protocols, GCP, and regulatory requirements. This role is remote-based and ideal for an experienced CRA with a strong background in Oncology trials and Pharma sponsor collaborations. Experience with IVD studies is highly desirable.

Key Responsibilities

• Conduct routine monitoring visits including site initiation, interim, and close-out visits.
• Ensure compliance with ICH-GCP, German regulations, and study-specific protocols.
• Perform source data verification and ensure accurate documentation in the eTMF.
• Build and maintain effective relationships with site staff, investigators, and sponsors.
• Identify and address site performance or compliance issues proactively.
• Support study start-up activities, including EC / IRB submissions and site feasibility assessments.
• Collaborate with project management, data management, and medical teams to ensure timely and quality trial delivery.

Requirements

• Minimum 5 years of CRA experience, with significant exposure to Pharma-sponsored trials.
• Proven experience in Oncology trials; additional therapeutic areas are a plus.
• Experience with IVD studies is desirable.
• Deep understanding of GCP, ICH, and German regulatory requirements.
• Fluent in German (native or near-native) and professional English.
• Ability to travel across Germany as required.
• Strong organizational, communication, and problem-solving skills.
• Self-motivated, proactive, and comfortable working remotely.

Why Apply

• Join a highly respected European CRO delivering cutting-edge clinical research.
• Work in a remote-based role with flexibility and autonomy.
• Engage in Oncology-focused, high-impact clinical trials in collaboration with leading Pharma sponsors.