Clinical Research Associate

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

Zusammenfassung

A global clinical research organization in Germany is seeking a Clinical Research Associate (CRA) to ensure compliance with clinical trials. Responsibilities include monitoring trial conduct, managing investigational sites, and ensuring data integrity. The ideal candidate should possess a degree in Health Sciences, 6-12 months of CRA experience, and be fluent in English and German. This full-time position offers a competitive remuneration package.

Qualifikationen

• 6-12 months’ CRA work experience.
• ICH GCP training (desirable).
• Ability to handle stressful situations and multitask.

Aufgaben

• Ensure compliance with trial protocols and regulations.
• Conduct pre-study visits at investigational sites.
• Monitor trial conduct and ensure data accuracy.

Kenntnisse

Fluent in English and German

Strong communication skills

Organizational skills

Ability to work independently

Proficient in computer 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 clinical trials at selected investigational sites complies with the approved protocol/amendments, 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 ensure the rights of subjects are respected and 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 guidelines, local and international legislation, including data protection laws.
• Report deviations from protocols, guidelines, or legislation to the Line Manager according to SOPs.
• Conduct pre-study visits to evaluate potential investigational sites.
• Collaborate with Regulatory Affairs and Clinical Operations for submissions and contracts, managing hospital IEC submissions and approvals.
• Prepare study contracts and relevant documentation for financial management.
• Explain study purposes, setup, and procedures to Investigators; provide training and support.
• Maintain and update Clinical Trial Files, ensuring proper collection of documents.
• Supply sites with study medication, verify drug accountability, and oversee shipment, storage, and disposal.
• Monitor trial conduct at sites, ensuring Investigator compliance and qualifications, verifying data, and verifying informed consent procedures.
• Manage safety reporting, AE/SAE training, and ensure timely submissions to authorities.
• Verify proper dispensing of study drugs and document all monitoring activities.
• Participate in meetings, support audits and inspections, and collaborate on feasibility assessments.
• Assist with financial issues, manage subject enrollment, and optimize patient procedures.
• Participate in departmental planning, SOP development, 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 work experience.
• Fluent in English and German, both oral and written.
• ICH GCP training (desirable).
• Proficient in computer skills.
• Strong communication and organizational skills.
• Ability to work independently and as part of a team.
• Effective communication with site personnel.
• Ability to handle stressful situations, flexible with timelines, and multitask.
• Adherence to SOPs, guidelines, regulations, and ethical principles.
• Willingness to travel frequently, including evenings and overnight stays.

Join our multidisciplinary team of scientists and healthcare professionals in a friendly work environment. We offer a competitive remuneration package.

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