How is this different from the Clinical Research Coordinator track?

The CRC track teaches the job from the per-study view: consenting a participant, recording the data, reporting the event. This one teaches the portfolio view that sits above it, with submissions and amendments and safety pipelines coordinated across every open study at once. That 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 and has no course fee; the CRC track is not required. What this track does assume is operational familiarity with how a site runs, whether from coordination, regulatory work, or equivalent exposure.

Is the certificate included?

Yes. The certificate is part of the price, and the credential is valid two years. Nothing more falls due.

Is it a subscription?

No. One payment opens the track permanently, with nothing to renew.

Is it aligned to ICH E6(R3)?

Every course is grounded in E6(R3) as adopted on 6 January 2025, with specific guideline sections cited throughout rather than gestured at: quality management, essential records under Appendix C, safety reporting. Every reference was checked against the final guideline text.

Professional track

Regulatory Coordinator

One study is a task. A portfolio is a system.

A regulatory coordinator is not a coordinator with extra paperwork. The role owns a site's regulatory function across every study running at once: submissions, amendments, safety correspondence, essential records, and the state of readiness an inspector will find on arrival. This track begins where the coordinator's job ends, and teaches that function as a system rather than a stack of tasks.

The program record

Course sequence: 7 required courses
Curriculum: 47 modules · 180 lessons
Assessment and study extent: 7 final exams · approximately 67 hours
Credential: Regulatory Coordinator credential · valid 2 years

For Regulatory Coordinators, Senior CRCs Moving Into Regulatory, Site Managers & Research Directors, and CRO Site Management Professionals.

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Professional track

Regulatory Coordinator

One study is a task. A portfolio is a system.

The program record

Course sequence: 7 required courses
Curriculum: 47 modules · 180 lessons
Assessment and study extent: 7 final exams · approximately 67 hours
Credential: Regulatory Coordinator credential · valid 2 years

For Regulatory Coordinators, Senior CRCs Moving Into Regulatory, Site Managers & Research Directors, and CRO Site Management Professionals.

One-time purchase · no subscription

Verifiable credential and printable certificate included

Course access does not expire

Recommended foundation

Begin with Good Clinical Practice (GCP).

Good Clinical Practice is the recommended starting point. The CRC track is not required, but this track assumes operational familiarity with how a research site runs.

View free GCP training

The work this program teaches

Portfolio-level IRB submissions, multi-board navigation, and reliance
Protocol amendments, from impact assessment through implementation tracking
Safety reporting coordination across every study a site runs
Essential records infrastructure, and the discipline of staying inspection-ready

The learning experience

A lesson reader built for the workday.

Read at your pace, resume where you left off, and inspect preview lessons before you enroll.

Progress saved as you go
18 preview lessons
7 final exams

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Academy lesson reader · illustrative view

Module III · Lesson 3 of 6

Central Monitoring & Key Risk Indicators

How centralized review complements site monitoring, and what its signals mean for the records you keep.

Explain how central monitoring can complement site review
Distinguish a key risk indicator from a quality tolerance limit
Keep site records that read cleanly to a central reviewer

ICH E6(R3) describes monitoring as a broad range of activities. Sponsors tailor the approach to the trial’s design and identified risks, using site, remote, and centralized monitoring as appropriate.

Centralized monitoring evaluates accumulated data in a timely way. It can reveal systemic or site-specific issues, complement site monitoring, or help target where closer review is needed.

ICH E6(R3) · §3.10“The sponsor should implement an appropriate system to manage quality throughout all stages of the trial process.”

The program

The regulatory function, course by course.

The sequence follows the work itself. Every course is required for the credential.

7 courses · 47 modules · 180 lessons · approximately 67 hours

IThe Regulatory Coordinator: Role, Scope & Professional IdentityRequired6 modules · 22 lessons
View The Regulatory Coordinator: Role, Scope & Professional Identity course
Course note
Defines the Regulatory Coordinator's competency, stakeholder relationships, portfolio-level thinking, and professional identity -- where the CRC track ends, this course begins.
Modules
1. 01The regulatory function at the investigator site4 lessons
2. 02The RC across organizational settings4 lessons
3. 03Stakeholder relationships and accountability structures4 lessons
4. 04Portfolio thinking: managing across studies4 lessons
5. 05The regulatory coordinator's quality mindset3 lessons
6. 06Professional identity and career architecture3 lessons
Assessment
- 45 questions
- 80% to pass
- 60 minutes
- 3 attempts
IIRegulatory Submissions & Stakeholder ManagementRequired8 modules · 31 lessons
View Regulatory Submissions & Stakeholder Management course
Course note
Master portfolio-level IRB submission management, multi-IRB navigation, regulatory authority interactions, and stakeholder communication for the Regulatory Coordinator role.
Modules
1. 01The submission pipeline: portfolio-level operations4 lessons
2. 02Initial submissions: building complete packages4 lessons
3. 03Continuing review and regulatory maintenance4 lessons
4. 04IRB models and reliance agreements5 lessons
5. 05Regulatory authority interactions at the site level4 lessons
6. 06Stakeholder communication in the submission process3 lessons
IIIProtocol Amendment ManagementRequired6 modules · 23 lessons
View Protocol Amendment Management course
Course note
Master portfolio-level protocol amendment management -- from impact assessment and IRB submission through implementation tracking and regulatory communication.
Modules
1. 01Anatomy of a protocol amendment4 lessons
2. 02IRB submission of amendments4 lessons
3. 03Consent revision and reconsent management4 lessons
4. 04Implementation tracking and cascading changes4 lessons
5. 05Portfolio-level amendment management4 lessons
6. 06Regulatory communication deliverable: amendment coordination3 lessons
IVSafety Reporting CoordinationRequired6 modules · 24 lessons
View Safety Reporting Coordination course
Course note
Manage the site-level safety reporting pipeline across a multi-study portfolio -- sponsor communications, IRB reports, investigator coordination, and the systems that prevent safety reporting failures.
Modules
1. 01The safety reporting ecosystem from the RC's chair4 lessons
2. 02Processing sponsor safety communications4 lessons
3. 03IRB safety reporting and unanticipated problems4 lessons
4. 04Investigator safety assessment coordination4 lessons
5. 05Safety reporting across the portfolio4 lessons
6. 06Safety communication deliverables and process improvement4 lessons
VEssential Records Infrastructure & Document ManagementRequired7 modules · 28 lessons
View Essential Records Infrastructure & Document Management course
Course note
Design site-level records infrastructure that governs how every study's essential records are organized, stored, version-controlled, and retrieved -- from ICH E6(R3) Appendix C essentiality framework through electronic systems compliance and portfolio-level coordination.
Modules
1. 01The essentiality framework: ICH E6(R3) Appendix C4 lessons
2. 02Designing the site's records architecture4 lessons
3. 03Version control and document currency4 lessons
4. 04Electronic systems and regulatory compliance4 lessons
5. 05Records quality management4 lessons
6. 06
VIInspection Readiness and Regulatory Quality ManagementRequired7 modules · 27 lessons
View Inspection Readiness and Regulatory Quality Management course
Course note
Build and lead a site-wide inspection readiness program grounded in continuous quality management -- from gap analysis and CAPA through sponsor audits, FDA inspections, and regulatory QMS design at the portfolio level.
Modules
1. 01Inspection readiness as a continuous state4 lessons
2. 02Gap analysis and self-inspection4 lessons
3. 03CAPA in the regulatory domain4 lessons
4. 04Managing sponsor audits and regulatory inspections4 lessons
5. 05Regulatory quality management systems4 lessons
6. 06Portfolio-level quality oversight3 lessons
VIIRegulatory Operations Leadership and Career ProgressionRequired7 modules · 25 lessons
View Regulatory Operations Leadership and Career Progression course
Course note
Lead, improve, and scale a site's regulatory operations function — and chart the next step in your career.
Modules
1. 01Building and managing a regulatory team4 lessons
2. 02Training, competency, and knowledge management4 lessons
3. 03Process improvement in regulatory operations4 lessons
4. 04Metrics, reporting, and demonstrating value4 lessons
5. 05Change management and organizational resilience4 lessons
6. 06Career progression3 lessons

Audience

Who the program is for.

Regulatory Coordinators
Senior CRCs Moving Into Regulatory
Site Managers & Research Directors
CRO Site Management Professionals

The credential

A public record of completion.

When you pass, the Academy issues a dated record in your name at its own verification URL, and the included certificate is ready to download.

Credential: Regulatory Coordinator
Curriculum version: v1.0
Study extent: approximately 67 hours
Validity: 2 years
Verification: mytrial.com/verify

Verify any credential

Included · public verification record

The credential

Public verification record

Awarded to: Amina Okafor · illustrative
Issued: 14 Aug 2026 · illustrative
Credential ID: MTA-TR-202608-R6C024
Credential: Regulatory Coordinator
Curriculum: v1.0
Validity: 2 years
Verification: mytrial.com/verify

Illustrative record · issued when you pass

Included · printable certificate

Illustrative MyTrial Academy Regulatory Coordinator certificate for Amina Okafor — Illustrative certificate specimen · not a live credential

The things people ask first.

What it costs, what you earn, and how the program runs.

What does a regulatory coordinator actually 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. Where a coordinator handles regulatory tasks for one study, this role builds the systems those tasks run inside.
How is this different from the Clinical Research Coordinator track?: The CRC track teaches the job from the per-study view: consenting a participant, recording the data, reporting the event. This one teaches the portfolio view that sits above it, with submissions and amendments and safety pipelines coordinated across every open study at once. That 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 and has no course fee; the CRC track is not required. What this track does assume is operational familiarity with how a site runs, whether from coordination, regulatory work, or equivalent exposure.
Is the certificate included?: Yes. The certificate is part of the price, and the credential is valid two years. Nothing more falls due.
Is it a subscription?: No. One payment opens the track permanently, with nothing to renew.
Is it aligned to ICH E6(R3)?: Every course is grounded in E6(R3) as adopted on 6 January 2025, with specific guideline sections cited throughout rather than gestured at: quality management, essential records under Appendix C, safety reporting. Every reference was checked against the final guideline text.

07Study closure and final regulatory notifications3 lessons

08Portfolio timeline management in the submission context4 lessons

Assessment

55 questions
80% to pass
75 minutes
3 attempts

48 questions
75% to pass
75 minutes
3 attempts

Assessment

48 questions
75% to pass
75 minutes
3 attempts

Records lifecycle management

07Portfolio-level records coordination4 lessons

Assessment

50 questions
80% to pass
75 minutes
3 attempts

07Regulatory communication deliverables: quality and compliance4 lessons

Assessment

50 questions
80% to pass
90 minutes
3 attempts

Capstone: comprehensive regulatory operations assessment

Assessment

45 questions
80% to pass
75 minutes
3 attempts

The portfolio view, taught as a system.

27,900 clinical research professionals in over 168 countries have trained with the Academy. Good Clinical Practice has no course fee and comes first; take this one for the day the regulatory binder stops being an extra duty and becomes the job.

Program fee

$179 USD

One-time purchase · verifiable credential included

Program fee

$179 USD

One-time purchase · verifiable credential included

$179 USD

Already a member? Sign in to apply your rate

One-time purchase · no subscription
Verifiable credential and printable certificate included
Course access does not expire

Preview a free lesson Read the full syllabus

Program fee

$179 USD

One-time purchase · verifiable credential included

Regulatory Coordinator

Regulatory Coordinator

Begin with Good Clinical Practice (GCP).

A lesson reader built for the workday.

Central Monitoring & Key Risk Indicators

IThe Regulatory Coordinator: Role, Scope & Professional IdentityRequired6 modules · 22 lessons

IIRegulatory Submissions & Stakeholder ManagementRequired8 modules · 31 lessons

IIIProtocol Amendment ManagementRequired6 modules · 23 lessons

IVSafety Reporting CoordinationRequired6 modules · 24 lessons

VEssential Records Infrastructure & Document ManagementRequired7 modules · 28 lessons

VIInspection Readiness and Regulatory Quality ManagementRequired7 modules · 27 lessons

VIIRegulatory Operations Leadership and Career ProgressionRequired7 modules · 25 lessons

Who the program is for.

A public record of completion.

Public verification record

The portfolio view, taught as a system.