Principal Clinical Research Associate (PCRA) / Klinischer Monitor – Full-Time or Part-Time...

## About the Role

We are seeking a highly experienced Principal Clinical Research Associate (CRA) to lead and coordinate all aspects of clinical monitoring and site management for complex clinical trials. Acting as a subject-matter expert and site process specialist, you will ensure trials are conducted in accordance with the approved protocol, ICH-GCP, applicable regulatory requirements, and internal SOPs—ensuring subject safety, data integrity, and continuous audit readiness.

In this principal-level role, you will manage complex and high-risk studies across multiple sponsor and monitoring models (e.g. FSO, FSP, government-sponsored research). You will serve as a key escalation point for sites and project teams, take a leadership role on assigned studies, and actively contribute to the mentoring and development of junior and senior CRAs alike.

## What You’ll Do

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## Principal-Level Clinical Monitoring & Oversight

• Lead monitoring activities for complex, high-risk, or strategically important clinical trials using a risk-based monitoring approach
• Independently conduct on-site and remote monitoring visits in line with approved monitoring plans
• Perform and oversee SDR, SDV, and CRF review, ensuring the highest standards of data accuracy and integrity
• Evaluate investigational product accountability through physical inventory and records review
• Ensure essential documents are complete, inspection-ready, and compliant with ICH-GCP and applicable German/EU regulations
• Lead site initiation, maintenance, and close-out activities, providing expert guidance and recommendations

Quality, Risk & Issue Management

• Apply advanced root cause analysis (RCA), critical thinking, and problem-solving methodologies to identify systemic site issues
• Strategic Project & Stakeholder Collaboration
• Serve as a trusted partner to investigative sites, sponsors, and internal project teams
• Identify trends across sites and studies and provide strategic recommendations to the Clinical Team Manager (CTM)
• Ensure accurate and timely updates of study systems (e.g. CTMS) and perform QC reviews where required
• Participate in investigator meetings and support investigator identification and feasibility activities
• Support investigator payment processes and trial financial oversight as applicable

Leadership, Mentorship & Process Improvement

• Actively mentor, coach, and support the development of junior and senior CRAs
• Contribute to project-specific and functional training initiatives
• Identify opportunities for process optimization and drive implementation of improvements
• Provide expert input into monitoring strategies and clinical operations best practices

Administrative & Operational Responsibilities

• Maintain timely and accurate completion of timesheets, expense reports, and required documentation
• Maintain frequent communication with sites between visits to ensure ongoing compliance and issue resolution
• Drive corrective and preventive actions (CAPAs) to resolution and proactively mitigate risk
• Author high-quality monitoring reports and follow-up correspondence in a timely manner
• Act as a key escalation point for significant site issues, protocol deviations, and compliance risks
• Support and lead activities related to audits, inspections, and regulatory inquiries

## Education & Experience

• Bachelor’s degree in a life sciences related field or equivalent qualification
• Minimum 5+ years of experience as a Clinical Research Associate / Monitor
• Valid driver’s license
• Full right to work in Germany
• Fluency in German and English (C1 level) – interviews will be conducted in German

Knowledge, Skills & Abilities

• Strong clinical monitoring skills with hands-on RBM experience
• Excellent understanding and application of ICH-GCP and applicable regulations
• Solid therapeutic area knowledge and medical terminology
• Well-developed critical thinking, problem-solving, and root cause analysis skills
• Strong written and verbal communication skills with medical professionals
• High attention to detail and strong organizational skills
• Ability to work independently while contributing effectively to cross-functional teams
• Flexibility and adaptability in a dynamic project environment
• Proficiency in Microsoft Office and ability to learn clinical systems (e.g., CTMS)

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Locations: Home-based or hybrid anywhere in Germany

FTE: Full-time (40 hrs/week) or Part-time 80% (32 hrs/week)

Contract: Permanent

Travel: Approximately 50–75% (study-dependent)

• Severely disabled applicants with the same aptitude will be given preferential treatment.

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Quelle: Statistisches Bundesamt (Destatis), Tabelle; dl-de/by-2-0; eigene Berechnung

Veröffentlicht am 30. Okt. 2026