Clinical Research Associate

Veeda Lifesciences; Frankfurt; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A global CRO is seeking a Clinical Research Associate based in Frankfurt, Germany. The successful candidate will ensure compliance with regulations and manage clinical trial activities. Key qualifications include a degree in Health Sciences and fluency in English and German. This is a full-time position offering a competitive remuneration package.

Leistungen

Competitive remuneration package

Qualifikationen

• 6-12 months of CRA experience required.
• ICH GCP training is desirable.
• Ability to handle stressful situations and manage timelines.

Aufgaben

• Ensure compliance with quality management systems and regulations.
• Conduct feasibility assessments and site evaluations.
• Monitor clinical trial conduct, including recruiting and data collection.

Kenntnisse

Fluent in English

Fluent in German

Organizational skills

Computer skills

Effective communication skills

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

He/she serves as the primary communication link for operational study activities between the Sponsor, Investigators, and study personnel, aiming to foster successful working relationships.

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

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 stay updated on amendments.
• Report deviations from approved protocols, GCP guidelines, or legislation during study conduct to the Line Manager and relevant roles per SOPs.
• Conduct pre-study visits to potential sites for feasibility assessments and resource evaluation.
• Collaborate 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, providing training and ongoing support.
• Maintain and update Clinical Trial Files, ensuring collection of essential documents.
• Ensure proper study medication supply, verify drug accountability, and oversee shipment, storage, dispensing, and destruction.
• Monitor clinical trial conduct at sites, including verifying investigator qualifications, data accuracy, and compliance with the protocol and GCP.
• Verify informed consent procedures and ensure timely recruitment and data collection.
• Report safety information and ensure investigators are trained in AE/SAE reporting.
• Ensure timely submissions to IEC/IRB and regulatory authorities.
• Manage drug accountability and proper dispensing.
• Document monitoring activities and communicate findings to investigators and the CRA manager.
• Participate in study meetings, audits, and inspections, facilitating corrective actions.
• Support feasibility assessments, site selection, and study closure activities.
• Contribute to departmental planning and SOP development.
• Provide coaching and mentorship 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 in teams.
• Effective communication skills, diplomatic and assertive.
• Ability to handle stressful situations, manage timelines, and multitask.
• Adherence to SOPs, regulations, and ethical principles.
• Willingness to travel frequently, including evenings and overnight stays.

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

Competitive remuneration package included.

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