CRA II/Sr CRA - Sponsor-Dedicated FSP - Germany (m/f/d)

Clinical Research Associate

This position is for experienced Clinical Research Associates with 2+ years of independent monitoring experience. You will manage clinical trial sites across Germany, ensuring studies are conducted in compliance with the protocol, ICH-GCP, applicable regulations, and company SOPs.

You'll work autonomously, partner closely with investigative sites, and collaborate with project teams to deliver high-quality, inspection-ready clinical trials.

What You'll Do

• Perform site monitoring activities (on-site and remote) using a risk-based monitoring approach
• Ensure protocol, ICH-GCP, regulatory, and SOP compliance at investigator sites
• Conduct SDR, SDV, CRF review, and investigational product accountability
• Identify, document, escalate, and follow up on issues through resolution, applying root cause analysis and CAPA principles
• Maintain audit and inspection readiness at all assigned sites
• Build strong, collaborative relationships with investigators and site staff
• Document monitoring activities in timely, high-quality reports and follow-up letters
• Maintain ongoing communication with sites between visits to support issue resolution and data quality
• Ensure study systems (e.g., CTMS) are updated according to study conventions
• Provide trial status updates and metrics to the Clinical Team Manager (CTM)
• Support study start-up, investigator identification, site initiation, and study close-out activities as assigned
• Participate in investigator meetings, audits, inspections, and project team meetings as required

Additional responsibilities may include supporting process improvement initiatives, mentoring activities, or project-specific tasks aligned with experience.

A Day in the Life

• Review site metrics and prioritize monitoring activities based on risk
• Conduct on-site or remote monitoring visits
• Partner with sites to resolve findings and improve processes
• Collaborate with CTMs and project teams to keep studies on track and inspection-ready
• Complete documentation, system updates, and administrative tasks

Education & Experience

• Bachelor's degree in a life sciences related field or equivalent qualification
• Minimum 2 + 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 English & German

• 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)

Locations: Home-based or hybrid anywhere in Germany FTE: Full-time (40 hrs/week)Contract: Permanent Travel: Approximately 50–75% (study-dependent)