What does a regulatory coordinator do?

A regulatory coordinator owns the site’s regulatory function across every study running at once: IRB submissions, protocol amendments, safety correspondence, essential records, and the state of readiness an inspector finds on arrival.

How is this different from the CRC track?

The CRC track teaches the job from the per-study view. This one teaches the portfolio view above it, with submissions, amendments and safety pipelines coordinated across every open study. It is a different discipline, not a harder version of the same one.

Do I need the CRC track first?

No. Good Clinical Practice is the recommended starting point; its training, exams and online credential are free, and the optional PDF certificate is $29 USD. This track does assume you know how a research site runs.

What does the fee include?

All seven courses and their final exams, the public verification record and the printable certificate. It is a one-time purchase, not a subscription.

How long does the training take?

About 67 hours across seven self-paced courses. Your progress saves as you go.

Is it aligned to ICH E6(R3)?

Every course is grounded in E6(R3) as adopted on 6 January 2025, citing specific guideline sections: quality management, essential records under Appendix C, and safety reporting.

Regulatory Coordinator Training

Regulatory Coordinator training for the whole portfolio.

Seven self-paced courses on a site’s regulatory function: submissions and reliance, amendments, safety correspondence, essential records and inspection readiness.

One payment of $179 USD. The certificate is included, and course access does not expire.

The Regulatory Coordinator certificate, included in the fee. Shown here with sample details.

Regulatory Coordinator

Where the coordinator’s per-study work ends, this track begins: the portfolio view, grounded in ICH E6(R3).

Courses: 7
Lessons: 180
Study time: ~67 h

Pass every final exam and your credential is issued, with the printable certificate included.

$179 USD

One-time purchase. No subscription and no expiry on access. The verifiable credential is included, together with the printable certificate.

Enroll

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Most employers reimburse this. There is a letter you can send them.

$179 USD

One-time purchase. No subscription and no expiry on access. The verifiable credential is included, together with the printable certificate.

Enroll

Most employers reimburse this. There is a letter you can send them.

Course I · 6 modules · 22 lessons The Regulatory Coordinator: Role, Scope & Professional Identity
Defines the Regulatory Coordinator's competency, stakeholder relationships, portfolio-level thinking, and professional identity -- where the CRC track ends, this course begins.
1. The regulatory function at the investigator site4 lessons
2. The RC across organizational settings4 lessons
3. Stakeholder relationships and accountability structures4 lessons
4. Portfolio thinking: managing across studies4 lessons
5. The regulatory coordinator's quality mindset3 lessons
6. Professional identity and career architecture3 lessons
Final exam 45 questions · 80% to pass · 60 minutes · 3 attempts
View The Regulatory Coordinator: Role, Scope & Professional Identity course

Regulatory Coordinator training for the whole portfolio.

Regulatory Coordinator training for the whole portfolio.

What the program teaches

The courses that earn your regulatory credential.

Regulatory Coordinator

Regulatory training, built like a reference book.

Who the track is written for

Your regulatory credential. Online to verify, on paper to keep.

Verification record

Printable certificate

Questions about regulatory training

Begin the regulatory program, and run the portfolio as a system.