Clinical Development Monitor (CRA)
りんしょうかいはつもにたー（しーあーるえー）
Industry & Occupation
Classification
Summary
A specialist who belongs to pharmaceutical companies or CROs, monitors clinical trials (investigational studies) conducted at medical institutions to ensure compliance with GCP and protocols, and secures data quality and subject safety.
Description
Clinical Development Monitors (CRAs) belong to pharmaceutical companies or CROs and are responsible for the quality of clinical trials (investigational studies) and subject protection. They regularly visit clinical trial sites to confirm compliance with protocols and GCP. They inspect case report forms, informed consent documents, electronic data capture systems (EDC), and follow up on corrective and preventive actions (CAPA). They also support smooth trial progress through coordination with investigational medical institutions and information sharing with project teams.
Future Outlook
With the increase in global trials and decentralized clinical trials, demand is steadily growing. Skills in remote monitoring technology and data science utilization will contribute to enhancing future market value.
Personality Traits
Able to pay attention to details / Able to take initiative / Excellent communication skills / Strong sense of responsibility
Work Style
Domestic and International Travel / Fieldwork / Flexible Work System / Pharmaceutical Company Employment / Remote Monitoring
Career Path
Clinical Development Monitor (CRA) → Senior CRA → Clinical Development Leader → Clinical Project Manager → Clinical Development Department Manager
Required Skills
Coordination with Investigational Study Medical Institutions / Creation and Implementation of Monitoring Plans / EDC System Operation / GCP Knowledge / Management of Investigational Study-Related Documents
Recommended Skills
Automation Tools (for CRA) / Basics of Statistics / English Paper Reading Comprehension
Aptitudes (Strengths Preferred)
| Item | Description |
|---|---|
| Attention to Detail & Accuracy | To ensure the accuracy of trial data and compliance with GCP. |
| Communication Skills | To smoothly coordinate and report with medical institution staff and project teams. |
| Learning Agility & Knowledge Acquisition | Because it is necessary to quickly respond to changes in ICH guidelines and regulatory requirements. |
| Physical Stamina & Endurance | Because it involves frequent domestic and international business trips and long hours of on-site visits. |
| Planning & Organization | Because it is necessary to efficiently manage multiple site visits and tasks. |
Aptitudes (Weaknesses Acceptable)
| Item | Description |
|---|---|
| Creativity & Ideation | Because the work mostly follows standardized procedures, and generating new ideas is not particularly required. |
Aliases
- CRA
- Clinical Monitor
Related Jobs
- Clinical Development Consultant
- Clinical Development Coordinator (CRC)
- Clinical Project Manager