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

Evidenze; Essen; Vor Ort; EUR 60.000 - 85.000; Vollzeit

Benefits dieser Stelle

Hybrid working

Professional development

Career progression

Zusammenfassung

Evidenze, a full-value CRO in Germany, is hiring a Clinical Research Associate (CRA II) to ensure successful trial delivery in compliance with GCP and regulatory standards. You will collaborate with investigative sites, study teams and external partners to conduct sites responsibly and efficiently.

The role requires a life sciences degree, a Master’s in Clinical Research or equivalent, CRA experience, and fluency in German and English.

Qualifikationen

• Degree in a Life Sciences or Health Sciences discipline.
• Master's Degree in Clinical Research or equivalent.
• Previous experience as a CRA in Clinical Trials.
• Strong knowledge of GCP/ICH-GCP and current regulations.
• Fluent in German and English (written and spoken).
• Willingness to travel as required.
• Strong organizational, planning 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 study protocols and GCP/regulations.
• Monitor progress including regulatory approvals and recruitment.
• Review CRFs per monitoring plan and study requirements.
• Coordinate with investigative sites and external vendors.
• Report and follow up on adverse events.
• Document protocol deviations and corrective actions.
• Maintain trial documentation and study files.
• Assist with site payment management and cross-functional collaboration.

Kenntnisse

GCP knowledge

Fluent German

Fluent English

Ausbildung

Bachelor's degree in Life Sciences/Health Sciences

Master's degree 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.

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)

About Us

We are Evidenze, an international healthcare company that operates as a “Full Value” CRO, specializing in clinical research and the generation of scientific evidence. We support pharmaceutical and biotechnology companies throughout the entire product lifecycle, from early-stage research to real-world studies.

We combine scientific expertise, technology, and strategic consulting to transform data into actionable insights, improve clinical practice, and deliver real value to the healthcare system.