puestos de Scientist en Alemania

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.

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. They act as the primary communication link between the Sponsor, Investigators, and study personnel to foster successful working relationships. A key responsibility is to safeguard subjects' rights and ensure that clinical trial data are accurate, complete, and source verifiable.

• 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 procedures as necessary.
• Report deviations from protocols, guidelines, or legislation to the Line Manager according to SOPs.
• Conduct pre-study visits to evaluate investigational sites' resources and facilities.
• Collaborate with Regulatory Affairs and Clinical Operations for submissions, contracts, and approvals, including hospital IEC submissions.
• Explain study purposes and procedures to Investigators, providing training and support for trial conduct.
• Prepare and maintain clinical trial documentation, ensuring proper collection of essential documents.
• Manage study medication supplies, verify drug accountability, and oversee safe shipment, storage, and disposal.
• Monitor clinical trial conduct, ensuring Investigator compliance and qualifications, verifying data accuracy against source documents, and confirming informed consent procedures are followed.
• Coordinate safety reporting, ensuring timely submission of reports and AE/SAE training for Investigators.
• Ensure timely regulatory submissions and proper drug dispensing.
• Document monitoring activities and communicate findings to Investigators and the CRA team.
• Participate in meetings, provide progress feedback, and prepare for audits or inspections.
• Support feasibility assessments, site selection, and study enrollment management.
• Assist with financial management, including Investigator payments.
• Oversee study site closures after trial completion.
• Participate in departmental planning, SOP development, and team coaching, especially for new CRAs.
• Monitor the DACH region.

• Bachelor’s or Master’s degree in Health Sciences or related field.
• 6-12 months’ experience as a CRA.
• Fluent in English and German, both written and spoken.
• ICH GCP training (preferred).
• Proficient in computer skills and good communication, organizational, and interpersonal skills.
• Ability to work independently and as part of a team, handle stressful situations, and manage multiple issues simultaneously.
• Compliance with SOPs, regulations, and ethical principles.
• Willingness to travel frequently, including international trips, evenings, and overnight stays.

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

Competitive remuneration package included.

We prioritize data protection and respect your privacy. For details on data processing, please visit our Privacy Notice to Candidates: https://heads-research.com/candidates-privacy-notice/