Clinical Research Associate

Veeda Lifesciences; Leipzig; Vor Ort; EUR 45.000 - 55.000; Vollzeit

Zusammenfassung

A global CRO is seeking a Clinical Research Associate (CRA) in Germany. The ideal candidate will be responsible for ensuring compliance in clinical trials, managing documentation, and collaborating with investigators. Fluency in English and German is required, along with 6-12 months of CRA experience. A competitive remuneration package is offered.

Leistungen

Competitive remuneration package

Qualifikationen

• 6-12 months’ CRA experience required.
• Experience with ICH GCP training preferred.
• Proficient in computer skills and general communication.

Aufgaben

• Ensure compliance with clinical trial protocols and guidelines.
• Manage clinical trial files and documentation.
• Monitor trial conduct at investigational sites.

Kenntnisse

Fluent in English and German

Strong organizational skills

Effective communication skills

Ability to work independently

Ausbildung

Bachelor’s or master’s degree in Health Sciences or related field

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 that the conduct of clinical trials at selected investigational sites complies with the approved protocol and amendments, ICH GCP guidelines, SOPs, and applicable laws and regulations.

The CRA acts as the primary communication link between the Sponsor, Investigator, and study personnel to foster successful working relationships.

The key responsibility is to safeguard subjects’ rights and ensure that all clinical trial data are accurate, complete, and verifiable from source documents.

Main responsibilities :

• Ensure compliance with the company’s Quality and Information Security Management Systems, ICH GCP, relevant legislation, including data protection laws, and update protocols accordingly.
• Report deviations from protocols, GCP guidelines, or legislation to the Line Manager and relevant roles as per SOPs.
• Conduct pre-study visits to evaluate investigational sites’ resources and facilities.
• Coordinate with Regulatory Affairs and Clinical Operations for submissions and contracts, including hospital IEC submissions, study contracts, and financial documentation.
• Explain study purposes and procedures to Investigators, and provide training and support for trial conduct.
• Manage and update clinical trial files, ensuring proper documentation and collection of essential documents.
• Supply sites with study medication, verify drug accountability, and oversee shipment, storage, dispensing, and destruction as applicable.
• Monitor trial conduct at sites, ensuring investigator compliance, verifying qualifications, reviewing data, and ensuring informed consent is obtained.
• Coordinate safety reporting and ensure timely submissions to IEC/IRB or regulatory authorities.
• Manage drug accountability and proper dispensing of study drugs.
• Document monitoring activities and communicate findings to investigators and management.
• Participate in study meetings, and assist in audits and inspections.
• Support feasibility assessments, site selection, and enrollment management.
• Contribute to SOP development and departmental planning.
• Provide coaching and mentorship to less experienced CRAs.
• Monitor the DACH region.

Job Requirements :

• Bachelor’s or master’s degree in Health Sciences or related field.
• 6-12 months’ CRA experience.
• Fluent in English and German (oral and written).
• Experience with ICH GCP training preferred.
• Proficient in computer skills and general communication.
• Strong organizational skills and ability to work independently and collaboratively.
• Effective communication skills, capable of handling stressful situations and tight timelines.
• Willingness to travel frequently, including international trips, evenings, and overnight stays.

Join our multidisciplinary team of scientists and healthcare professionals in a dynamic clinical research environment.

Competitive remuneration package offered.

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