Clinical Research Associate

AL Solutions; Leipzig; Vor Ort; EUR 50.000 - 65.000; Vollzeit

Zusammenfassung

A leading company in Leipzig is seeking a motivated Clinical Research Associate to support clinical trial operations. The role involves monitoring sites to ensure compliance, data accuracy, and engagement throughout the study lifecycle. The successful candidate will work closely with site staff and internal teams, ensuring regulatory standards are met and timelines are adhered to. This position offers the opportunity to contribute to critical research in a dynamic environment.

Qualifikationen

• 1–4 years of experience in clinical site monitoring.
• Strong command of clinical trial guidelines, including ICH-GCP.

Aufgaben

• Conduct monitoring visits to ensure compliance with protocol requirements.
• Monitor site performance for patient safety and data quality.
• Educate site personnel on study procedures.

Kenntnisse

Organizational Skills

Communication Skills

Time Management

Ausbildung

Degree in Life Sciences

Degree in Pharmacy

Degree in Nursing

Jobbeschreibung

We are seeking a motivated Clinical Research Associate to support clinical trial operations through comprehensive on-site and remote monitoring. This individual will play a crucial role in ensuring regulatory compliance, data accuracy, and site engagement throughout the study lifecycle.

Core Responsibilities :

• Conduct monitoring visits—including site qualification, initiation, routine monitoring, and close-out—to ensure clinical trial conduct aligns with protocol requirements and regulatory standards.
• Monitor site performance to verify patient safety, protocol adherence, data quality, and regulatory documentation.
• Assist in identifying and evaluating potential sites across therapeutic areas.
• Educate and support site personnel on study procedures and ensure essential documentation is properly maintained.
• Review subject data and source documentation for accuracy, completeness, and timely entry into electronic case report forms (eCRFs).
• Validate that informed consent is properly documented and that investigational product is stored and administered according to guidelines.
• Ensure timely resolution of data queries and that adverse events, including SAEs, are reported in compliance with study and regulatory expectations.
• Support audit readiness and address any quality assurance observations in a timely manner.

What Success Looks Like :

• Consistently meeting timelines and quality metrics for monitoring deliverables.
• Clear, thorough reporting and follow-up after site visits.
• Positive and proactive engagement with site staff and internal teams.

Key Relationships :

• Reports functionally and administratively to the Clinical Operations Manager.
• Collaborates with other CRAs, clinical team members, site coordinators, and operational support teams.

Qualifications :

• Degree in Life Sciences, Pharmacy, Nursing, or a related field.
• 1–4 years of experience in clinical site monitoring.
• Strong command of clinical trial guidelines, including ICH-GCP.
• Excellent organizational, communication, and time-management skills.
• Capable of managing multiple priorities in a dynamic and deadline-driven environment.

Clinical Research Associate • Leipzig, DE