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. Enroll once to access all courses and exams.
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
6 modules, 22 lessons, and 6 knowledge checks — all self-paced.
4 lessons · 3 hours
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.
Enroll in the Regulatory Coordinator track to access this course, all exams, and your certificate.
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. Enroll once to access all courses and exams.
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
6 modules, 22 lessons, and 6 knowledge checks — all self-paced.
4 lessons · 3 hours
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.
Enroll in the Regulatory Coordinator track to access this course, all exams, and your certificate.
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
Establishes the conceptual distinction that defines the RC track: the difference between executing regulatory tasks for one study and operating the regulatory system for a site's full portfolio
Examines how multiple regulatory frameworks generate overlapping and sometimes conflicting obligations at the site level, and how the RC reconciles them
Traces the operational forces that created the RC role through three decades of regulatory evolution and projects where the role is heading
4 lessons · 3 hours
Examines the RC role within academic medical centers, where institutional bureaucracy, investigator autonomy, and multiple IRB structures shape regulatory operations
Examines the RC role within dedicated research organizations where high study volume, standardized SOPs, and performance metrics shape regulatory operations
Addresses the RC role in resource-constrained settings where the RC may also serve as lead CRC and must build regulatory infrastructure from scratch
Examines how CRO-managed site networks and decentralized trial models are reshaping the RC role and which regulatory functions remain irreducibly site-local
4 lessons · 3 hours
Addresses the most consequential relationship in the RC's professional life: navigating the line between supporting and assuming the investigator's regulatory responsibilities.
Examines the RC-CRC working relationship from the RC's perspective: delegation design, handoff documentation, and proportionate oversight
Addresses the RC's portfolio-level relationship with sponsors and CRAs: standardizing monitoring visit management and analyzing cross-study patterns
Examines the RC as the site's primary interface with IRBs/IECs and regulatory authorities, managing these relationships strategically across the portfolio
4 lessons · 3 hours
Introduces portfolio thinking as the defining intellectual competency of the RC role — the mental model shift from serial task management to parallel portfolio management
Teaches the RC to build and maintain a portfolio-level regulatory timeline that makes deadline clusters and resource conflicts visible weeks or months in advance
Teaches systematic approaches to resource allocation, bottleneck identification, and workload distribution that prevent deadline crises from becoming compliance failures
Teaches the RC to apply E6(R3) risk-based thinking to portfolio management, stratifying studies by regulatory complexity and building tiered oversight models
3 lessons · 2 hours
Applies the quality management system framework from E6(R3) Section 3.10 to site-level regulatory operations, teaching the RC to think about quality as system design
Teaches the RC to identify the Critical to Quality factors in regulatory processes and design monitoring indicators that detect quality degradation before it causes compliance failures
Addresses how the RC manages regulatory deviations across the portfolio — building prevention systems, detecting cross-study patterns, and implementing CAPA for systemic issues
3 lessons · 2 hours
Addresses the professional identity question every RC must answer: what makes you different from a very experienced CRC, and how to articulate that distinction
Provides an honest, operationally grounded analysis of the certification landscape from the RC's perspective, evaluating which credentials validate systems-level competencies
Maps the career pathways available to experienced regulatory coordinators and provides a framework for designing a three-year professional development plan
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
Establishes the conceptual distinction that defines the RC track: the difference between executing regulatory tasks for one study and operating the regulatory system for a site's full portfolio
Examines how multiple regulatory frameworks generate overlapping and sometimes conflicting obligations at the site level, and how the RC reconciles them
Traces the operational forces that created the RC role through three decades of regulatory evolution and projects where the role is heading
4 lessons · 3 hours
Examines the RC role within academic medical centers, where institutional bureaucracy, investigator autonomy, and multiple IRB structures shape regulatory operations
Examines the RC role within dedicated research organizations where high study volume, standardized SOPs, and performance metrics shape regulatory operations
Addresses the RC role in resource-constrained settings where the RC may also serve as lead CRC and must build regulatory infrastructure from scratch
Examines how CRO-managed site networks and decentralized trial models are reshaping the RC role and which regulatory functions remain irreducibly site-local
4 lessons · 3 hours
Addresses the most consequential relationship in the RC's professional life: navigating the line between supporting and assuming the investigator's regulatory responsibilities.
Examines the RC-CRC working relationship from the RC's perspective: delegation design, handoff documentation, and proportionate oversight
Addresses the RC's portfolio-level relationship with sponsors and CRAs: standardizing monitoring visit management and analyzing cross-study patterns
Examines the RC as the site's primary interface with IRBs/IECs and regulatory authorities, managing these relationships strategically across the portfolio
4 lessons · 3 hours
Introduces portfolio thinking as the defining intellectual competency of the RC role — the mental model shift from serial task management to parallel portfolio management
Teaches the RC to build and maintain a portfolio-level regulatory timeline that makes deadline clusters and resource conflicts visible weeks or months in advance
Teaches systematic approaches to resource allocation, bottleneck identification, and workload distribution that prevent deadline crises from becoming compliance failures
Teaches the RC to apply E6(R3) risk-based thinking to portfolio management, stratifying studies by regulatory complexity and building tiered oversight models
3 lessons · 2 hours
Applies the quality management system framework from E6(R3) Section 3.10 to site-level regulatory operations, teaching the RC to think about quality as system design
Teaches the RC to identify the Critical to Quality factors in regulatory processes and design monitoring indicators that detect quality degradation before it causes compliance failures
Addresses how the RC manages regulatory deviations across the portfolio — building prevention systems, detecting cross-study patterns, and implementing CAPA for systemic issues
3 lessons · 2 hours
Addresses the professional identity question every RC must answer: what makes you different from a very experienced CRC, and how to articulate that distinction
Provides an honest, operationally grounded analysis of the certification landscape from the RC's perspective, evaluating which credentials validate systems-level competencies
Maps the career pathways available to experienced regulatory coordinators and provides a framework for designing a three-year professional development plan