Nationally Certified Multi-Skilled Clinical Research Assistant
CIP Code: 51.0919 • 125 questions • 2.5 hours • Passing score: 70% • Annual renewal
Overview
This credential validates multi-skilled readiness to support clinical trials across start-up, conduct, and close-out. Certified Clinical Research Assistants coordinate participant visits, manage source documentation and EDC entries, assist with informed consent and safety reporting, and maintain regulatory readiness across site operations.
- Nationally recognized Multi-Skilled Stackable
- Listed in the NHWCA National Registry for employer verification
- Annual renewal: $199 • 10 CEU • No lapse (CPR not required)
Why Multi-Skilled?
NHWCA’s multi-skilled model verifies cross-functional competency in informed consent support, protocol procedures, EDC/data integrity, AE/SAE reporting, recruitment/scheduling, and regulatory readiness—so sponsors and sites can trust one certified team member to cover multiple study needs.
Job Description
A Clinical Research Assistant supports investigators and coordinators with participant screening and scheduling, visit prep, source documentation, EDC entry, query resolution, sample logistics, temperature logs, investigational product accountability support, and IRB/regulatory file maintenance.
Qualifications (choose one)
- Graduate of an allied health or clinical research program; or
- Trained on the job by an accredited research site, hospital, or academic center; or
- Experience: 3 months verifiable clinical research site experience.
All candidates must meet age, ID, and conduct requirements per the NHWCA Candidate Handbook.
Exam Structure & Timing
| Element | Detail |
|---|---|
| Question Count | 125 multiple-choice (100 scored + 25 pilot) |
| Time Limit | 2.5 hours (150 minutes) |
| Passing Score | 70% or higher |
| Delivery | Online or approved testing site, proctored, closed-book |
| Question Style | Scenario-based and knowledge-based items |
Exam Domains & Weighting
| Domain | Weight | Approx. Questions |
|---|---|---|
| Informed Consent, GCP & Ethics | 20% | ~25 |
| Protocol Procedures & Source Documentation | 20% | ~25 |
| Data Management, EDC & Query Resolution | 20% | ~25 |
| Safety Reporting (AE/SAE) & Risk Management | 15% | ~19 |
| Regulatory Binder, IRB & Compliance | 15% | ~19 |
| Recruitment, Scheduling & Participant Support | 10% | ~12 |
Totals reflect 100 scored items; 25 pilot items do not affect score.
Practice Questions (10)
Included with registration inside the candidate portal. These do not affect your score but mirror the style and depth of the live exam.
Renewal
- Cycle: Annual
- Requirements: $199 • 10 CEU • No lapse (CPR not required)
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