Sponsor dedicated Clinical Trial Assistant in Cologne area

Fortrea; Deutschland; Hybrid; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A clinical research organization is seeking a Sponsor-Dedicated Clinical Trial Associate (CTA) to support global study operations in the Cologne area. The ideal candidate has a Bachelor’s degree, is fluent in German and English, and has 2-3 years of clinical research experience. Responsibilities include managing study logistics, ensuring compliance, and supporting process improvements in a hybrid work environment.

Leistungen

Career Growth & Development

Supportive Work Environment

Competitive Benefits Package

Qualifikationen

• 2-3 years of experience in clinical research.
• Familiarity with clinical trial processes and project timelines.
• Experience in the healthcare field or pharmaceutical industry.

Aufgaben

• Assist the global study team with delegated tasks to ensure compliance.
• Manage study documentation and communications.
• Oversee and update operational tracking tools.
• Coordinate logistics for internal and external meetings.
• Maintain documentation quality for regulatory submissions.
• Act as a liaison between Medical Affairs and internal teams.
• Contribute to departmental process improvements.

Kenntnisse

Fluent in German and English

Clinical research experience

Knowledge of GCP/ICH Guidelines

Project management skills

Ausbildung

Bachelor of Science degree or equivalent

Jobbeschreibung

Are you passionate about advancing healthcare through clinical research? As a sponsor-dedicated CTA, you'll play a pivotal role in managing and coordinating clinical studies, contributing to groundbreaking medical discoveries.

This role is for upcoming future opportunities that may arise at Fortrea

It offers hybrid model possibility in the Cologne - area (client-office based).

Responsibilities:

• Support Global Study Operations: Assist the global study team with delegated tasks, ensuring compliance with GCP, regulatory standards, and sponsor's internal procedures.
• Coordinate Study Logistics & Communication: Manage study documentation, internal and external communications, training materials, and vendor system access across various platforms.
• Maintain Study Tracking Systems: Oversee and update operational tools (e.g., CTMS, eTMF...), track study progress, and generate reports for study leadership.
• Organize Meetings & Events: Lead logistical coordination for internal and external meetings, including investigator meetings, vendor kick-offs, and training sessions.
• Ensure Documentation Quality: Maintain and audit the Trial Master File (eTMF) for completeness and compliance, supporting regulatory submissions.
• Support Outsourced Studies: Act as a liaison between Medical Affairs, CROs, and internal teams.
• Drive Process Improvement: Contribute to departmental initiatives and special projects aimed at enhancing operational efficiency and quality.

Requirements:

• Bachelor of Science degree preferred or an equivalent scientific or commercial Higher Vocational Education with preferably experience in the healthcare field, pharmaceutical industry or clinical research.
• Fluent in German and English, both written and verbal
• 2-3 years of experience in clinical research
• Familiarity with clinical trial processes, protocol designs, study procedures, and project timelines.
• Knowledge of GCP/ICH Guidelines and applicable regulatory authority requirements.

What we Offer

• Career Growth & Development: Gain hands-on experience in clinical research with opportunities for professional training and career advancement.
• Supportive Work Environment: Be part of a collaborative and dynamic team, working alongside experienced professionals in a sponsor-dedicated role.
• Competitive Benefits Package that also involve flexible working arrangements, access to wellness programs and feel included by joining Employees Resource Groups to build relationships and expand your network.

Join us in shaping the future of clinical research while building a fulfilling career!

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