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

Evidenze

Essen

Hybrid

EUR 60,000 - 86,000

Full time

8 hours ago
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Benefits offered by this job

Hybrid working model
Immediate start

Job summary

Evidenze in Germany is seeking a Clinical Research Associate (CRA II) to drive the successful delivery of clinical trials while ensuring GCP, ICH-GCP compliance and regulatory requirements. You will work with investigative sites, study teams and external partners to conduct site visits, monitor progress, handle regulatory approvals and ensure data quality.

This permanent full-time role offers a hybrid working model, ongoing training and clear opportunities for career progression, with immediate

Qualifications

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

Responsibilities

  • Conduct and manage site selection, initiation, monitoring and close-out visits.
  • Ensure trials comply with study protocols, GCP and regulations.
  • Monitor progress including approvals, recruitment, CRF completion and queries.
  • Review CRFs per monitoring plan and study requirements.
  • Coordinate with investigative sites and external vendors, including labs.
  • Report and follow up on adverse events.
  • Document protocol deviations and corrective actions.
  • Maintain trial documentation and study files.
  • Support site payment management activities.
  • Collaborate with multidisciplinary teams to ensure delivery.

Skills

GCP and ICH-GCP knowledge
Fluent German and English
Travel willingness
Independent work & teamwork

Education

Bachelor's degree in Life Sciences or Health Sciences
Master's degree in Clinical Research or equivalent

Job description

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.

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