Job Title: CRA I/ CRA II - Clinical Trial Services
Location: Remote, Germany
Job Type: Regular Full-time
Division: Precision for Medicine – Clinical Solutions
Requisition Number: 5610
Estimated Salary: €55,000 – €80,000 annually (depending on experience)
Job Summary:
Precision for Medicine is hiring a Clinical Research Associate I / Clinical Research Associate II to join our Germany-based remote team. Focused on oncology and rare disease, our CRO stands out through an exceptional culture and notably high CRA retention rates. You’ll work on 1–2 studies at a time, becoming a protocol expert with reasonable travel requirements and strong work-life balance.
Key Responsibilities:
Manage study sites to ensure data integrity and patient safety.
Independently conduct all types of site visits (pre-study, initiation, monitoring, close-out).
Ensure audit readiness and support for audit preparations.
Track regulatory and site documents in study-specific systems.
Support startup procedures: site feasibility, IRB/EC submissions, consent documents, and investigator contracts.
Review informed consent processes and assess safety/data integrity risks.
Maintain study documentation including letters, logs, and visit reports.
Review Investigator Site Files (ISFs) and reconcile with Trial Master File (TMF).
Communicate effectively with both site personnel and internal project teams.
Manage investigational product (IP) supply, security, labeling, and return processes.
Perform data review tasks such as EDC query resolution and patient profile checks.
Identify and escalate site-level risks with proposed mitigations.
Attend investigator meetings, project team discussions, and clinical training sessions.
Travel up to 60% domestically and internationally as needed.
Minimum Qualifications:
Bachelor’s degree in life sciences, pharmacy, or a related healthcare field.
At least 1.5 years of experience as a CRA in a CRO, biotech, or pharma environment.
Familiarity with clinical site management and regulatory processes.
Strong organizational, communication, and client-facing skills.
Comfortable using systems for data entry, documentation, and communication.
Fluent in English and the local language (German).
Preferred Qualifications:
Postgraduate degree.
Experience with oncology (preferably early-phase trials) or rare/complex diseases.
Familiarity with EDC systems, electronic health records, and site startup processes.
Prior experience in budget negotiation and investigator contract execution.
Ability to resolve issues and manage workload with minimal supervision.
Core Competencies:
Self-motivated and organized; works well independently or in teams.
Solid understanding of clinical trial methodology and GCP/ICH compliance.
Delivers professional, timely communication with internal and external stakeholders.
High-quality data collection and presentation skills.
Note:
Please apply in English. Be aware of potential employment scams. Our official hiring process includes direct interaction with our recruiters and a formal interview process.
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