Clinical Research Associate II (CRA II)| Germany| Hybrid

Antares Consulting SA; Essen; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Benefits dieser Stelle

Permanent full-time employment

Hybrid working model

Professional development

Career progression

Zusammenfassung

Evidenze in Germany is seeking a Clinical Research Associate II to manage sites and ensure trials meet GCP/ICH-GCP standards. You will monitor progress, ensure regulatory compliance, and collaborate with investigative sites and vendors to support successful study delivery.

The ideal candidate holds a Life Sciences degree, a Master’s in Clinical Research, CRA experience, and fluency in German and English. Travel willingness and strong organizational skills are essential.

Qualifikationen

• Degree in a Life Sciences or Health Sciences discipline.
• Master's Degree in Clinical Research or equivalent experience.
• Previous CRA experience in Clinical Trials.
• Strong knowledge of GCP, ICH-GCP, and current trial regulations.
• Fluent German and English, written and spoken.
• Willingness to travel.
• Strong organisational and communication skills.
• Ability to work independently and in a team.

Aufgaben

• Conduct site selection, initiation, monitoring and close-out visits.
• Ensure trials comply with protocols, GCP/ICH-GCP and regulations.
• Monitor study progress: approvals, recruitment, CRF completion.
• Review CRFs per monitoring plan and study requirements.
• Coordinate with sites and external vendors including labs.
• Report and follow-up on adverse events.
• Document trial activities and maintain study files.
• Support site payments and cross-functional collaboration.

Kenntnisse

GCP

ICH-GCP

Regulations

German/English

Travel

Organisational skills

Team collaboration

Ausbildung

Life Sciences degree

Master's in Clinical Research

Jobbeschreibung

Join us

At Evidenze, we are passionate about advancing healthcare and improving patients' quality of life. With more than 400 professionals and a comprehensive portfolio of services across clinical research, patient support programmes, medical education, communications and events, we support innovation throughout the healthcare sector.
As part of our continued growth, we are looking for a Clinical Research Associate II (CRA II) to join our Clinical Operations team in Germany. This is an excellent opportunity for an experienced CRA who is looking to take the next step in their career within a collaborative, supportive and well-established organisation.

About the Role

As a Clinical Research Associate (CRA II), you will play a key role in ensuring the successful delivery of clinical trials while maintaining the highest standards of GCP, ICH-GCP compliance, and regulatory requirements. You will work closely with investigative sites, study teams and external partners to ensure studies are conducted efficiently, ethically and in accordance with protocol requirements.

Key Responsibilities

• Conduct and manage site selection, site initiation, monitoring and close-out visits.
• Ensure clinical trials are conducted in compliance with study protocols, Good Clinical Practice (GCP) guidelines, applicable regulations and standard operating procedures.
• Monitor study progress, including regulatory approvals, patient recruitment, CRF completion and query management.
• Review CRFs in line with the monitoring plan and study requirements.
• Support communication and coordination between investigative sites and external vendors, including central laboratories.
• Ensure appropriate reporting and follow-up of adverse events.
• Identify, document and support the management of protocol deviations and corrective action plans.
• Contribute to the preparation, review and maintenance of clinical trial documentation and study files.
• Support site payment management activities.
• Collaborate effectively with multidisciplinary teams to ensure successful study delivery.

Essential Requirements

• Degree in a Life Sciences or Health Sciences discipline, such as Pharmacy, Biochemistry, Biology or a related field.
• Master's Degree in Clinical Research or equivalent professional experience.
• Previous experience working as a Clinical Research Associate (CRA) within Clinical Trials.
• Strong knowledge of GCP, ICH-GCP, and current clinical trial regulations.
• Fluent German and English communication skills, both written and spoken.
• Willingness and availability to travel as required.
• Strong organisational, planning and communication skills.
• Ability to work independently while contributing effectively within a team environment.

Preferred Qualifications

• Previous experience in Onco-Haematology / Oncology Clinical Trials.
• Additional language skills beyond English.

What we offer

• Permanent full-time employment contract.
• Hybrid working model combining remote work and office-based collaboration.
• Opportunity to join a well-established and growing organisation within the clinical research sector.
• Continuous professional training and development.
• Supportive leadership and a collaborative team environment.
• Clear opportunities for professional growth and career progression.
• Competitive salary aligned with experience, skills and qualifications.
• Immediate start available.

Location & Working Model

Germany
Hybrid Working (combination of remote and office-based work)

Ready for Your Next Career Move?

If you are an experienced CRA, passionate about Clinical Monitoring, Clinical Trials, and delivering high-quality research in compliance withGCP/ICH-GCP standards, we would love to hear from you.