Clinical Research Associate

R&D Partners; Deutschland; Vor Ort; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

A leading research organization is seeking a Clinical Research Associate in Germany. This role involves planning and coordinating clinical research studies, ensuring compliance with regulatory requirements, and collaborating with various teams. The ideal candidate will have a Bachelor's Degree in a scientific discipline and at least one year of experience in a similar position. Excellent communication skills and the ability to work with diverse teams are essential.

Qualifikationen

• Minimum of 1 year of experience as a Clinical Research Associate.
• Experience in a clinical laboratory or study coordination is a plus.
• Strong understanding of good clinical practices.

Aufgaben

• Act as the primary contact for assigned study site personnel.
• Perform site assessment and qualification visits.
• Ensure compliance with regulatory requirements.

Kenntnisse

Clinical research processes

Regulatory requirements

Excellent communication

Organizational skills

Ability to work in global teams

Ausbildung

Bachelor's Degree in a scientific discipline

Jobbeschreibung

Join us as a Clinical Research Associate and help turn data into discoveries that change lives.

R&D Partners is seeking a Clinical Research Associate to join our team. This role involves designing, planning, coordinating, and conducting activities related to initiating, monitoring, and completing clinical research studies at clinical study sites. The ideal candidate will ensure that studies are delivered, recorded, and reported in compliance with protocols, standard operating procedures, good clinical practices, and applicable regulatory requirements.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities

• Operate under the mentorship or guidance of experienced Site Management team members.
• Act as the primary contact for assigned study site personnel, including training and certification coordination.
• Perform site assessment and qualification visits to assist in site selection decisions.
• Ensure site activation, contracting, IRB/EC/Health Authority approvals, and site initiation meet regulatory requirements.
• Contribute to the review of study-level documents (e.g., protocol, master ICF, study plans, study reports) and develop site-level documents.
• Collaborate cross-functionally with RD Field Service, Study Management, Biometrics, and other teams to deliver solutions.
• Conduct all data generation, validation, and site monitoring activities, including end-to-end site visits.
• Work with international investigators as needed.
• Adhere to regulations, guidelines, and standard operating procedures to ensure audit and inspection readiness.
• Validate product performance claims and support critical regulatory submissions.
• Build and maintain strong collaborative relationships with internal and external stakeholders.

Key Skills and Requirements

• Education: Bachelor's Degree in a scientific discipline or related field required (or equivalent combination of education and work experience). Experience in a clinical laboratory or clinical lab study coordination is a plus.
• Experience: Minimum of 1 year of experience as a Clinical Research Associate.
• Strong understanding of clinical research processes, regulatory requirements, and good clinical practices.
• Ability to work in local and global study teams, including virtual teams, with cultural awareness.
• Excellent communication and organizational skills.

For more information, please contact Elliott Croft.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.

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