🏅 Nationally Certified Clinical Research Assistant™ (NCCRA™)
The Nationally Certified Clinical Research Assistant (NCCRA) is a nationally recognized credential awarded by the National Clinical Research Certification Association™ (NCRCA™). This certification validates core competencies in clinical trial support, including data collection, regulatory documentation, patient coordination, and protocol compliance. Ideal for entry-level professionals, the NCCRA™ sets the standard for excellence in clinical research support across academic, hospital, and industry settings.
🧾 Credential Overview
The NCCRA™ credential is designed for entry‑level clinical research assistants and validates foundational competencies in supporting clinical trial operations. Ideal for roles involving data handling, regulatory documentation, participant coordination, and protocol compliance. It reflects alignment with Good Clinical Practice (GCP), FDA and ICH guidance.
🎯 Exam Outline & Percentage Breakdown
The exam is scenario‑based and multiple‑choice, assessing practical application aligned with NCRCA™ competencies. Here are the domains and approximate exam weightings:
| Domain | Approx. % of Exam |
|---|---|
| Data collection & entry | 30 % |
| Regulatory documentation | 25 % |
| Participant coordination | 20 % |
| Protocol compliance & ethics | 15 % |
| Communication & teamwork | 10 % |
| Total | 100% |
✅ Summary & Tips
- Format: Multiple-choice questions focused on real-world scenarios involving trial support.
- Focus Areas:
- Data entry into source documents and electronic CRFs (30%).
- Regulatory support: consent, file maintenance, protocol adherence (25%).
- Participant interactions: scheduling, consent assistance, liaison duties (20%).
- Ethical and protocol compliance under GCP/ICH/FDA (15%).
- Team communication in a clinical research setting (10%).
📌 Preparation Suggestions
- Study NCRCA’s published competency domains for the NCCRA credential thoroughly.
- Review GCP principles (FDA/ICH guidance), informed consent, protocol management, data quality and trial ethics.
- Prepare with scenario-based practice questions, focusing on real-world application rather than memorization.
💵 Fees & Cost to Apply
- Initial application/exam fee: Not explicitly listed online. (Please check NCRCA’s application portal for the current exam fee.)
- Annual renewal fee: $398, due each year at time of renewal.
- The fee is non-refundable and required at submission of the annual renewal package.
📚 Who Should Apply & Eligibility Requirements
Who should pursue the NCCRA® credential?
Ideal for entry-level practitioners in clinical research who support trial operations under supervision—such as data entry, participant coordination, regulatory documentation, and protocol adherence.
Eligibility requirements (based on NCRCA policies):
- Likely includes documentation of education (minimum high school diploma or equivalent).
- Demonstrated clinical research experience or employment in a supporting role.
- Compliance with Good Clinical Practice (GCP), ICH/FDA regulations.
- You’ll also need to provide employment verification when renewing (see maintenance requirements).
(Exact exam eligibility details should be confirmed on the NCRCA site or through direct contact—for example, proof of education, experience hours, or supervisor endorsement.)
🔄 Certification Maintenance Requirements
Annual renewal is mandatory to keep NCCRA® credential active. Requirements include:
- Employment Verification
- At least 500 hours of paid clinical research employment within the past year.
- Employment must be with an NCRCA-accredited employer.
- Continuing Education Units (CEUs)
- A minimum of 10 CEUs annually in relevant areas, including:
- GCP
- FDA & ICH regulations
- Human subject protection and ethics
- Protocol safety / job‑specific competencies.
- A minimum of 10 CEUs annually in relevant areas, including:
- Renewal Form Submission
- Complete the online Annual Certification Renewal Form.
- Upload CEU certificates and employment documentation.
- Pay the $398 renewal fee to submit package.
Program Cycle & Grace Period
- Certification is valid for one year; renewal annually.
- You receive a 30-day grace period after expiration. Certification is inactive during this window and may not be used if not renewed.
- If you fail to renew within that grace period, your credential will be revoked, and you’ll need to re-exam and reapply to reinstate.
📋 Summary Table
| Area | Details |
|---|---|
| Initial Exam Fee | Not publicly listed (check NCRCA portal) |
| Annual Maintenance Fee | $398 (non-refundable) |
| Who Should Apply | Entry-level research assistants in clinical trials settings |
| Eligibility | Education and research support experience (verify via NCRCA) |
| Employment Verification | 500 hours in past year with accredited employer |
| CEUs Required | 10 CEUs annually in relevant topics |
| Renewal Process | Form, document upload, and fee submission |
| Grace Period | 30 days after expiration; otherwise revoked |
✅ Why It Matters
Maintaining your NCCRA® ensures:
- Continued inclusion in the NCRCA national registry of certified professionals.
- Credential verification by employers, sponsors, and regulators.
- Demonstrates ongoing compliance with evolving research standards and ethics.