Clinical Research Training Academy

Course Description

In today’s clinical research environment, trials rarely fail due to science—they fail due to operational execution, decision-making gaps, and lack of strategic oversight. At the center of this challenge is one critical role: the Clinical Trial Manager (CTM). The Clinical Trial Leadership course is an executive-level program designed to transform high-performing Clinical Research Coordinators (CRCs), Clinical Research Associates (CRAs/Lead CRAs), and Jr. Clinical Trial Leads/Managers into strategic Clinical Trial Managers capable of leading complex studies from concept through close-out. This 2-day virtual training program goes beyond traditional training by focusing not on tasks—but on leadership, accountability, and decision-making under real-world condition. Each module includes CTM Responsibilities and Mock Exercises (Real-World Scenarios)

Course at a Glance

2-Day Live Virtual Workshop

2 Full Days of Interactive Learning

Intensive, instructor-led sessions

May 30-31,2026

Upcoming Virtual Workhop

9:00 AM - 4:00 PM EST

Small-group, live instructor-led sessions

Price : $1995.00 USD

Location:

Participate from anywhere with stable internet

Certificate of Completion from CRTA

Recognized professional credential

Faculty Director: Sonja Cooper

Limited Seats - Secure Your Spot Early!

Terms & Conditions

Learning Objectives

By the end of the program, participants will be able to:

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Transition from site-level execution to study-level leadership
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Make high-stakes operational decisions under uncertainty
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Design and implement risk-based monitoring strategies (RBQM)
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Lead cross-functional teams, CROs, and vendors
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Identify and mitigate enrollment, data quality, and compliance risks
•
Translate complex data into clear executive-level insights
•
Drive clinical trials toward successful, inspection-ready outcomes

Who Should Attend

•
Senior Clinical Research Coordinators (CRCs) ready to advance
•
Clinical Research Associates (CRAs) preparing for CTM roles
•
Newly appointed Clinical Trial Managers seeking to accelerate impact
•
Organizations developing future clinical operations leaders

Course Outline

Day 1: Foundations + Site Execution

Module 1: The Clinical Trial Ecosystem (Big Picture Thinking)

Objective: How roles impact trials success and CTM responsibilities

Topics:

•Drug vs Device vs Combination trials (operational differences)
•Sponsor, CRO, Site roles and responsibilities
•Where trials fail—and why (real examples)

CTM responsibilities

•Define operational model (Full CRO vs Hybrid)
•Align cross-functional stakeholders
•Set study success metrics (timelines, quality, enrollment)

Mock Exercise

Module 2: ICH-GCP in Real Life (Not Theory)

Objective: Apply GCP principles in daily work and CTM responsibilities

Topics:

•Key ICH-GCP principles translated into site actions
•ALCOA+ data integrity
•Informed consent pitfalls
•Protocol adherence vs real-world challenges

CTM Responsibilities

•Ensure GCP compliance across all sites
•Oversee training strategy (not just completion)
•Monitor protocol adherence trends

Mock Exercise

Module 3: Study Start-Up & Site Activation

Objective: Execute efficient site activation

Topics:

•Feasibility & site selection (what really matters)
•Regulatory documents & essential documents
•Contracts & budgets (what CRCs/CRAs should watch for)
•Site Initiation Visits (SIV): how to do them right

CTM Responsibilities

•Approve final site selection
•Drive startup timelines
•Ensure regulatory readiness

Mock Exercise

Module 4: Site-Level Trial Execution

Objective: Master day-to-day study conduct

Topics:

•Patient recruitment & retention strategies
•Visit execution (source → eCRF flow)
•Protocol deviations (how they happen + prevention)
•AE/SAE reporting workflows

CTM Responsibilities

•Monitor enrollment vs forecast
•Oversee protocol compliance trends
•Escalate underperforming sites

Mock Exercise

Day 2: Monitoring, Quality & Advanced Execution

Module 5: Monitoring & Oversight (CRA + CRC Alignment)

Objective: Understand how monitoring really works

Topics:

•On-site vs Remote vs Central Monitoring
•What CRAs look for
•Common findings during monitoring visits
•How CRCs can "pre-audit" their own work

CTM Responsibilities

•Define monitoring strategy (On-site vs RBM vs Central)
•Review monitoring reports for trends
•Ensure CRA effectiveness

Mock Exercise

Module 6: Risk-Based Quality Management (RBQM Made Simple)

Objective: Apply risk-based thinking without complexity

Topics:

•What are KRIs and QTLs (simplified)
•Critical data vs non-critical data
•Risk signals at the site level
•How to prevent audit findings proactively

CTM Responsibilities

•Define KRIs and QTLs
•Monitor risk signals
•Trigger corrective actions

Mock Exercise

Module 7: Data Quality & Inspection Readiness

Objective: Always be audit-ready

Topics:

•TMF vs ISF (what goes where)
•Common audit/inspection findings
•Source documentation best practices
•Query management and data cleaning

CTM Responsibilities

•Ensure TMF completeness
•Oversee data cleaning timelines
•Prepare for audit/inspection

Mock Exercise

Module 8: Close-Out & Study Completion

Objective: Finish strong and inspection-ready

Topics:

•Close-out visits (what's often missed)
•Drug/device accountability
•Final data reconciliation
•Archiving requirements

CTM Responsibilities

•Ensure database lock readiness
•Oversee final reconciliation
•Confirm site close-out completeness

Mock Exercise

Real-World Application

Participants will work through live clinical trial simulations, including:

•Oncology trial Enrollment delays, high screen failures, biomarker challenges
•Medical device trial: Data integrity issues, device failures, patient compliance risks

These simulations mirror the actual challenges CTMs face, ensuring immediate real-world applicability.