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Cra I/ Cra Ii - Clinical Trial Services

5+ years
€55,000 – €80,000
10 July 7, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.