Clinical Research Associate

Veeda Lifesciences; München; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A global CRO is seeking a Clinical Research Associate (CRA) in Munich, Germany. The CRA will ensure compliance with protocols and regulations for clinical trials while acting as a liaison among sponsors and investigators. Required qualifications include a degree in Health Sciences, experience in the field, and fluency in English and German. The role involves significant responsibilities in managing clinical trial logistics and ensuring data integrity.

Leistungen

Competitive remuneration package

Friendly working environment

Qualifikationen

• 6-12 months’ experience as a CRA.
• ICH GCP training preferred.
• Proficient in computer skills.

Aufgaben

• Ensure compliance with ICH GCP guidelines and regulations.
• Conduct pre-study visits to evaluate investigational sites.
• Monitor clinical trial conduct and data accuracy.

Kenntnisse

Fluent in English and German

Good communication skills

Organizational skills

Interpersonal skills

Independent work capability

Ability to handle stressful situations

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 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.

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 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.

Job Requirements:

• 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.

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