The Regulatory Coordinator Role: Scope & Professional Identity | RC Training
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.
Studied within the Regulatory Coordinator track. One payment of $179 USD covers all seven courses and the certificate.
Modules
6
Lessons
22
Knowledge checks
6
Study time
~about 7h
Final exam45 questions · 80% to pass · 60 minutes · up to 3 attempts
What you will be able to do
01Differentiate 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
02Analyze 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
03Map 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
04Evaluate 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
05Design a portfolio-level workload management framework that balances competing study timelines, regulatory deadlines, and resource constraints across a multi-study site
06Construct a professional development plan identifying certification pathways (ACRP, SoCRA, RAC), specialization opportunities, and leadership trajectories specific to regulatory operations
Six modules,one final exam.
Six modules and twenty-two lessons, each module closing with a knowledge check, and a final exam to complete the course.
A knowledge check closes every module
FreeThree lessons are open to read now
Pass the final exam at 80% to complete the course
IThe regulatory function at the investigator site4 lessons · knowledge check1 free lesson
1.1The regulatory function defined: what investigator sites must do, and who is responsibleRead free
Read three lessonsbefore you enroll.
Each is open now, exactly as enrolled learners read them. Every lesson in the course is written, cited and narrated the same way.
Module I · Lesson 120 min
The regulatory function defined: what investigator sites must do, and who is responsible
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.
The portfolio mindset: why managing 20 studies is not the same as managing one study 20 times
Introduces portfolio thinking as the defining intellectual competency of the RC role — the mental model shift from serial task management to parallel portfolio management
Career trajectories: from RC to regulatory management, consulting, and beyond
Maps the career pathways available to experienced regulatory coordinators and provides a framework for designing a three-year professional development plan
Studied as part ofthe Regulatory Coordinator track.
The Regulatory Coordinator: Role, Scope & Professional Identity is the first of seven courses in the Regulatory Coordinator track. It is not sold on its own: one enrollment opens every course, every final exam and the certificate.
Regulatory Coordinator
Portfolio-level regulatory operations training for clinical research sites
Courses
7
Lessons
180
Study time
~67 h
Pass every final exam and your credential is issued, with the printable certificate included.
$179 USDOne payment for the whole track. Access does not expire.
How it is enrolled in, what the exam asks, and what you can read first.
Can I take this course on its own?
Not separately. The Regulatory Coordinator: Role, Scope & Professional Identity is the first course in the Regulatory Coordinator track, and the track is enrolled in as one: all seven courses, every final exam and the certificate, for one payment of $179 USD.
What does the final exam ask?
Forty-five questions in 60 minutes, with 80% needed to pass, and up to three attempts. Each module also closes with a knowledge check.
Can I read any of it before I enroll?
Yes. Three lessons are open now: “The regulatory function defined: what investigator sites must do, and who is responsible”, “The portfolio mindset: why managing 20 studies is not the same as managing one study 20 times” and “Career trajectories: from RC to regulatory management, consulting, and beyond”.
Is it aligned to ICH E6(R3)?
Yes. The course works from ICH E6(R3).
Study The Regulatory Coordinator: Role, Scope & Professional Identity,within the Regulatory Coordinator track.
One enrollment opens all seven courses, every final exam and the certificate. Course access does not expire.
No. Access is yours for good. The Regulatory Coordinator credential the track awards is valid for two years.
$29 USD
of $179 USD
Can I take this course on its own?
Not separately. The Regulatory Coordinator: Role, Scope & Professional Identity is the first course in the Regulatory Coordinator track, and the track is enrolled in as one: all seven courses, every final exam and the certificate, for one payment of $179 USD.
Can I read any of it before I enroll?
Yes. Three lessons are open now: “The regulatory function defined: what investigator sites must do, and who is responsible”, “The portfolio mindset: why managing 20 studies is not the same as managing one study 20 times” and “Career trajectories: from RC to regulatory management, consulting, and beyond”.
Read three lessonsbefore you enroll.
Each is open now, exactly as enrolled learners read them. Every lesson in the course is written, cited and narrated the same way.
Module I · Lesson 120 min
The regulatory function defined: what investigator sites must do, and who is responsible
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.
The portfolio mindset: why managing 20 studies is not the same as managing one study 20 times
Introduces portfolio thinking as the defining intellectual competency of the RC role — the mental model shift from serial task management to parallel portfolio management
Career trajectories: from RC to regulatory management, consulting, and beyond
Maps the career pathways available to experienced regulatory coordinators and provides a framework for designing a three-year professional development plan
