Academy courseProfessional trackE6(R3)

The Regulatory Coordinator: Role, Scope & Professional Identity

The RC owns the regulatory infrastructure that allows a site to conduct clinical trials lawfully, efficiently, and at scale. This course defines that competency — mapping stakeholder relationships, introducing portfolio-level thinking, and establishing the professional identity that separates regulatory operations from regulatory task completion.

This course is part of the Regulatory Coordinator track. View the track for current enrollment options.

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Learning outcomes

What you'll be able to do

Differentiate the Regulatory Coordinator's portfolio-level responsibilities from the CRC's per-study execution role, identifying the specific competencies that distinguish systems management from task completion
Analyze the RC role across organizational settings (academic medical centers, dedicated research organizations, health system networks, CRO-embedded) and explain how site type shapes the scope of regulatory operations, applying the investigator qualification and delegation framework of ICH E6(R3) Annex 1, Sections 2.1-2.3 to the RC context
Map the RC's stakeholder relationships with PIs, CRCs, sponsors, CRAs, IRBs/IECs, and regulatory authorities, specifying the distinct communication requirements and accountability structures for each
Evaluate the regulatory implications of the investigator's responsibilities under ICH E6(R3) Annex 1, Sections 2.3 and 2.4 and explain how the RC supports -- but does not assume -- those obligations
Design a portfolio-level workload management framework that balances competing study timelines, regulatory deadlines, and resource constraints across a multi-study site
Construct a professional development plan identifying certification pathways (ACRP, SoCRA, RAC), specialization opportunities, and leadership trajectories specific to regulatory operations

Learn at your own paceAvailable through track enrollment

Full curriculum

6 comprehensive modules

6 modules, 22 lessons, and 6 knowledge checks — all self-paced.

Select any lesson to preview. Lessons marked Preview are free to read in full.

The regulatory function at the investigator site

4 lessons · 3 hours

Required

Conceptual illustration showing six interconnected regulatory obligation domains surrounding a central investigator site, with dependency lines illustrating how the domains form an integrated system

1.1 The regulatory function defined: what investigator sites must do, and who is responsible

Preview20 min

Maps the complete regulatory obligation set under ICH E6(R3) that falls on an investigator site, categorizes obligations by function, traces cascading dependencies, and identifies where the RC's domain begins.

Ready to begin The Regulatory Coordinator: Role, Scope & Professional Identity?

View the Regulatory Coordinator track for its current curriculum, price, and enrollment options.

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Review Curriculum Preview a lesson

The Regulatory Coordinator Role: Scope & Professional Identity | RC Training

Academy courseProfessional trackE6(R3)

The Regulatory Coordinator: Role, Scope & Professional Identity

This course is part of the Regulatory Coordinator track. View the track for current enrollment options.

View track

Learning outcomes

What you'll be able to do

Differentiate the Regulatory Coordinator's portfolio-level responsibilities from the CRC's per-study execution role, identifying the specific competencies that distinguish systems management from task completion
Analyze the RC role across organizational settings (academic medical centers, dedicated research organizations, health system networks, CRO-embedded) and explain how site type shapes the scope of regulatory operations, applying the investigator qualification and delegation framework of ICH E6(R3) Annex 1, Sections 2.1-2.3 to the RC context
Map the RC's stakeholder relationships with PIs, CRCs, sponsors, CRAs, IRBs/IECs, and regulatory authorities, specifying the distinct communication requirements and accountability structures for each
Evaluate the regulatory implications of the investigator's responsibilities under ICH E6(R3) Annex 1, Sections 2.3 and 2.4 and explain how the RC supports -- but does not assume -- those obligations
Design a portfolio-level workload management framework that balances competing study timelines, regulatory deadlines, and resource constraints across a multi-study site
Construct a professional development plan identifying certification pathways (ACRP, SoCRA, RAC), specialization opportunities, and leadership trajectories specific to regulatory operations

Learn at your own paceAvailable through track enrollment

Full curriculum

6 comprehensive modules

6 modules, 22 lessons, and 6 knowledge checks — all self-paced.

Select any lesson to preview. Lessons marked Preview are free to read in full.

The regulatory function at the investigator site

4 lessons · 3 hours

Required

1.1 The regulatory function defined: what investigator sites must do, and who is responsible

Preview20 min

Ready to begin The Regulatory Coordinator: Role, Scope & Professional Identity?

View the Regulatory Coordinator track for its current curriculum, price, and enrollment options.

View track

Review Curriculum Preview a lesson

The Regulatory Coordinator: Role, Scope & Professional Identity

What you'll be able to do

6 comprehensive modules

The regulatory function at the investigator site

1.1 The regulatory function defined: what investigator sites must do, and who is responsible

Ready to begin The Regulatory Coordinator: Role, Scope & Professional Identity?

The Regulatory Coordinator: Role, Scope & Professional Identity

What you'll be able to do

6 comprehensive modules

The regulatory function at the investigator site

1.1 The regulatory function defined: what investigator sites must do, and who is responsible

Ready to begin The Regulatory Coordinator: Role, Scope & Professional Identity?

1.2 From task list to operating system: how regulatory operations differ from regulatory tasks

1.3 The regulatory landscape from the site's chair: ICH, FDA, IRB/IEC, and sponsor requirements converging on your desk

1.4 Where the RC role came from: how growing trial complexity created a dedicated regulatory function

The RC across organizational settings

2.1 Academic medical centers: navigating institutional bureaucracy, IRB committees, and investigator autonomy

2.2 Dedicated research organizations: high volume, standardized processes, and the RC as operations manager

2.3 Health system networks and community practices: the RC wearing multiple hats

2.4 The emerging RC role in CRO site networks and virtual trial models

Stakeholder relationships and accountability structures

3.1 The PI-RC partnership: supporting the investigator's regulatory obligations without assuming them

3.2 Working with CRCs: delegation, oversight, and the handoff boundaries that matter

3.3 Sponsor and CRA interactions: what they expect, what they inspect, and how to manage the relationship at scale

3.4 IRB/IEC and regulatory authority relationships: the RC as the site's regulatory voice

Portfolio thinking: managing across studies

4.1 The portfolio mindset: why managing 20 studies is not the same as managing one study 20 times

4.2 Timeline architecture: mapping regulatory milestones across concurrent studies

4.3 Resource allocation and bottleneck identification: when everything is due the same week

4.4 Risk stratification across the portfolio: which studies need the most regulatory attention, and why

The regulatory coordinator's quality mindset

5.1 Quality management as a regulatory competency: ICH E6(R3) Section 3.10 applied to the site's regulatory function

5.2 Identifying Critical to Quality factors in regulatory operations

5.3 The RC's role in deviation prevention, detection, and correction at the portfolio level

Professional identity and career architecture

6.1 Building your regulatory coordinator identity: what distinguishes you from a senior CRC

6.2 Certification and credentialing: ACRP, SoCRA, RAC, and which ones matter for regulatory operations

6.3 Career trajectories: from RC to regulatory management, consulting, and beyond