Clinical Trial Clerk
ちけんじむいん
Industry & Occupation
Classification
Summary
Clinical Trial Clerks (CRCs) support the proper conduct of clinical trials, handling subject management, creation and management of trial-related documents, and coordination with trial implementation teams and pharmaceutical companies.
Description
Clinical Trial Clerks (Clinical Research Coordinators: CRCs) are professionals who support clinical trial operations for new drugs and medical devices in accordance with GCP (Good Clinical Practice). They handle a wide range of tasks including subject registration and consent acquisition, confirmation of protocol compliance, creation and management of case report forms (CRFs), preparation of application documents for ethics committees (IRBs), communication and coordination with trial sites, pharmaceutical companies, and SMOs, monitoring support, and trial progress management. High attention to detail, coordination skills, and understanding of relevant regulations are required, with career advancement opportunities to Clinical Development Monitors (CRAs) or Regulatory Affairs Specialists.
Future Outlook
Demand is expanding with the globalization of new drug development and the increase in clinical trials. Specialized skills including EDC and English proficiency are valued, and career paths to CRA or project manager are diversifying.
Personality Traits
Able to pay attention to details / Able to respond flexibly / Sociable / Strong sense of responsibility
Work Style
Contract employee / Dispatched employee / Hospital full-time / Pharmaceutical company employment / SMO employment
Career Path
Junior CRC → Senior CRC → CRA (Clinical Development Monitor) → Clinical Trial Project Manager → Regulatory Affairs Specialist
Required Skills
Application document preparation / CRF creation and management / GCP knowledge / Office software
Recommended Skills
Basics of statistics / Communication tool utilization / EDC system operation / English document reading
Aptitudes (Strengths Preferred)
| Item | Description |
|---|---|
| Attention to Detail & Accuracy | Because accuracy in documents and data is required. |
| Communication Skills | Because coordination with many stakeholders is necessary. |
| Learning Agility & Knowledge Acquisition | To respond to regulatory changes such as GCP. |
| Planning & Organization | Because trial planning and schedule management are important. |
| Collaboration & Teamwork | Because tasks are advanced through collaboration with multiple professions. |
Aptitudes (Weaknesses Acceptable)
| Item | Description |
|---|---|
| Creativity & Ideation | Because the work is mostly routine and does not require much creativity. |
| Physical Stamina & Endurance | Because it is mainly office work with low physical demands. |
Aliases
- CRC
- Clinical Trial Coordinator
Related Jobs
- Clinical Development Monitor (CRA)
- Medical Clerk
- Regulatory Affairs Specialist