Clinical Research Associate

Veeda Lifesciences; Stuttgart; Vor Ort; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

A leading global CRO is seeking a Clinical Research Associate (CRA) in Stuttgart, Germany, to ensure compliance in clinical trials for hematology/oncology. The ideal candidate has a degree in Health Sciences and 6-12 months' CRA experience, with proficiency in English and German. The role involves monitoring trial conduct at sites, maintaining accurate records, and supporting compliance with regulations. A competitive remuneration package is offered in a friendly work environment.

Leistungen

Competitive remuneration package

Qualifikationen

• 6-12 months' CRA experience required.
• ICH GCP training desirable.
• Proficient in computer skills and communication.

Aufgaben

• Ensure compliance with quality and security management systems.
• Conduct pre-study visits to assess site resources.
• Monitor trial conduct at sites and maintain site files.

Kenntnisse

Fluent in English

Fluent in German

Strong organizational skills

Effective communication skills

Ability to work independently and in a team

Ausbildung

Bachelor's or master's degree in Health Sciences

Jobbeschreibung

Heads, a global CRO and part of Veeda Lifesciences, is seeking a Clinical Research Associate (CRA) based in Germany for its expanding international hematology/oncology clinical trials program.

This is a full-time position.

Job overview :

The CRA is responsible for ensuring the conduct of clinical trials at selected investigational sites complies with approved protocols, ICH GCP guidelines, SOPs, and applicable laws and regulations. They serve as the primary communication link between the Sponsor, Investigators, and study personnel, fostering successful working relationships. The key responsibility is to safeguard subjects’ rights and ensure the accuracy, completeness, and verifiability of collected clinical data from source documents.

Main responsibilities :

• Ensure compliance with the company’s Quality and Information Security Management Systems, ICH GCP guidelines, local and international legislation, including data protection laws, and update protocols accordingly.
• Report deviations from protocols, guidelines, or legislation to the Line Manager following SOPs.
• Conduct pre-study visits to assess site resources, facilities, and feasibility.
• Collaborate with Regulatory Affairs and Clinical Operations for submissions and contracts, managing hospital IEC submissions, and preparing study contracts.
• Explain study purposes and procedures to Investigators, providing training and ongoing support.
• Maintain and update clinical trial files, ensuring proper documentation and collection of essential documents.
• Supply study medication, verify drug accountability, and oversee shipment, storage, dispensing, and destruction as required.
• Monitor trial conduct at sites, including verifying Investigator qualifications, reviewing data, ensuring informed consent, and maintaining site files.
• Report safety information, ensure timely submissions to IEC/IRB or regulatory authorities, and manage drug accountability.
• Document monitoring activities, participate in meetings, and prepare for audits or inspections.
• Support feasibility assessments, site selection, and study enrollment management.
• Participate in SOP development, departmental planning, and provide coaching to less experienced CRAs.
• Monitor the DACH region.

Job Requirements :

• Bachelor’s or master’s degree in Health Sciences preferred.
• 6-12 months’ CRA experience.
• Fluent in English and German, both oral and written.
• ICH GCP training (desirable).
• Proficient in computer skills and communication.
• Strong organizational skills and ability to work independently and as part of a team.
• Effective communication skills, capable of handling stressful situations and flexible timelines.
• Ability to manage multiple issues simultaneously, adhere to SOPs and regulations.
• Willingness to travel internationally and locally, including evenings and overnight stays.

Join our multidisciplinary team of scientists and healthcare professionals at the forefront of clinical research in a friendly work environment.

Competitive remuneration package provided.

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