Course Description

Program Philosophy

The Clinical Research Coordinator Career Accelerator (CRCCA) was developed to bridge the gap between traditional clinical research education and the practical skills required to succeed as a Clinical Research Coordinator. While many programs focus primarily on regulations and theory, employers increasingly seek professionals who can confidently contribute to study startup, participant recruitment, informed consent, regulatory compliance, study conduct, documentation, quality management, and day to day trial operations from the beginning of their careers.

The CRCCA is designed as an immersive, career focused learning experience that combines foundational knowledge with practical application, case based learning, faculty mentorship, and real world exercises. Throughout the program, participants will develop the operational competencies, professional confidence, and communication skills expected of successful Clinical Research Coordinators working in academic medical centers, hospitals, research networks, and industry sponsored clinical trials.

Rather than simply earning a certificate, participants graduate with a comprehensive CRC Readiness Portfolio consisting of practical work products completed throughout the program. This portfolio demonstrates real world competencies that can be presented to prospective employers during interviews and serves as evidence of both technical knowledge and practical readiness.

Course at a Glance

10-Week Live Virtual Career Accelerator Program

10 Week Program

2 Hour Live Interactive Session Each Week
Estimated Time Commitment: 4–6 Hours Per Week

Interactive, instructor-led workshops featuring case-based learning, practical exercises, faculty coaching, and real-world clinical research applications.

September 2026 Cohort

Weekly live virtual sessions with on-demand recordings.

Schedule

Sep. 12 – Nov. 21, 2026 | 10:00 AM – 12:00 PM EST

Tuition

US $2,495

Sep. 12 - Nov. 21, 2026

10 live virtual sessions on select Saturdays

Designed For

Aspiring CRCs, research assistants, healthcare professionals transitioning into clinical research, undergraduate and graduate students, and international medical graduates.

Key Topics

Clinical Trial Operations · GCP (ICH E6(R3)) · Informed Consent · Study Startup · Regulatory Affairs · Source Documentation · Quality Management · Clinical Research Finance · Career Development

Graduate With

Certificate of Completion
CRC Readiness Portfolio
Practical Templates & Checklists
Career Development Resources

Program Director

Margo Kamel, PhD, CCRC

Clinical Research Director

Why Choose CRCCA?

Move beyond theory with practical exercises, faculty mentorship, and a professional portfolio that demonstrates job-ready clinical research competencies.

Limited Enrollment

Small cohort size to maximize interaction, mentorship, and individualized feedback.

Terms & Conditions

Learning Objectives

Upon successful completion of the program, participants will be able to:

•
Explain the clinical research process from study startup through study closeout.
•
Apply Good Clinical Practice (ICH E6(R3)) and ethical principles in the conduct of clinical research.
•
Conduct and appropriately document the informed consent process.
•
Support study startup activities, participant visits, regulatory documentation, and day to day study operations.
•
Maintain accurate source documentation and essential study records.
•
Recognize common compliance issues and apply quality management principles.
•
Understand the fundamentals of clinical trial budgeting and site operations.
•
Communicate effectively with investigators, sponsors, participants, monitors, and research teams.
•
Demonstrate job readiness through completion of a CRC Readiness Portfolio.
•
Develop the professional skills needed to successfully obtain and excel in a Clinical Research Coordinator position.

Who Should Attend

•
Aspiring Clinical Research Coordinators (CRCs)
•
Research assistants
•
Healthcare professionals transitioning into clinical research
•
Undergraduate and graduate students
•
International medical graduates

Course Outline

Program Structure

Tier 1: Clinical Research Coordinator Career Accelerator (CRCCA)

Duration: 10 Weeks

Format

Weekly 2 hour live virtual sessions
Recorded lectures available on demand
Online learning modules
Interactive case discussions
Practical exercises and simulations
Faculty feedback and coaching
Downloadable templates and checklists
CRC Readiness Portfolio
Certificate of Completion

Estimated Time Commitment: 4 to 6 hours per week

Week 1

Foundations of Clinical Research

Develop a strong foundation in the clinical research enterprise by exploring clinical trial phases, research stakeholders, study teams, and the role of the Clinical Research Coordinator across academic medical centers, hospitals, research networks, and industry sponsored studies.

Participants will learn how CRCs contribute to successful study execution while gaining an understanding of the complete clinical trial lifecycle.

Practical Exercise Create a Clinical Trial Lifecycle Map.

Portfolio Deliverable Clinical Trial Lifecycle Map

Week 2

Good Clinical Practice (GCP) and Research Ethics in Practice

Develop a practical understanding of Good Clinical Practice (ICH E6(R3)), participant safety, protocol adherence, documentation standards, and research ethics.

Participants will apply these principles to realistic scenarios involving vulnerable populations, pediatric assent, protocol deviations, and regulatory expectations.

Practical Exercise Evaluate mock protocol deviation scenarios and develop appropriate corrective actions.

Portfolio Deliverable GCP Compliance Checklist

Week 3

Informed Consent, Health Literacy, and Participant Engagement

Master the informed consent process, including assent, parental permission, remote consent, participant recruitment, retention strategies, and effective communication.

Participants will learn to recognize and address health literacy challenges while tailoring communication to diverse participant populations.

Practical Exercise Conduct a mock informed consent discussion and develop a participant recruitment strategy.

Portfolio Deliverable Informed Consent Checklist and Recruitment Strategy

Week 4

Study Startup and Regulatory Fundamentals

Develop a practical understanding of feasibility assessments, site selection, IRB and single IRB submissions, essential regulatory documents, study startup activities, and site activation workflows.

Participants will work through a mock study startup package including the protocol, informed consent form, study budget, regulatory documents, and coverage analysis to develop a comprehensive site activation plan.

Practical Exercise Develop a Study Startup and Site Activation Plan.

Portfolio Deliverable Study Startup and Site Activation Plan

Week 5

Study Visits, Source Documentation, and Data Management

Learn participant visit preparation, scheduling, coordination with clinical teams, source documentation standards, electronic data capture systems, query management, and adverse event reporting.

Participants will practice maintaining accurate, complete, and audit ready documentation.

Practical Exercise Complete a mock participant visit documentation package.

Portfolio Deliverable Source Documentation Package

Week 6

Quality Management, Monitoring, Audits, and Inspection Readiness

Explore quality management systems, monitoring visits, audits, regulatory inspections, protocol deviations, and corrective and preventive action planning.

Participants will take part in a simulated monitoring visit and respond to real world quality findings.

Practical Exercise Develop a Corrective and Preventive Action (CAPA) Plan based on monitoring findings.

Portfolio Deliverable Monitoring Response and CAPA Plan

Week 7

Clinical Research Finance and Site Operations

Develop an understanding of clinical trial finances, including budget development, coverage analysis, participant reimbursement, invoicing, contract considerations, and financial tracking.

Participants will review sample study budgets and payment schedules to identify underfunded activities, negotiate key budget items, and monitor study financial performance throughout the study lifecycle.

Practical Exercise Review and evaluate a clinical trial budget.

Portfolio Deliverable Clinical Trial Budget Review and Financial Tracking Worksheet

Week 8

Managing Real World Clinical Trial Challenges

Apply structured problem solving to operational challenges including slow enrollment, protocol amendments, data quality issues, sponsor expectations, investigator engagement, and workflow inefficiencies.

Participants will learn practical approaches to study recovery using root cause analysis, communication strategies, and risk mitigation planning.

Practical Exercise Develop a Study Rescue Plan for a struggling clinical trial.

Portfolio Deliverable Study Rescue and Risk Mitigation Plan

Week 9

CRC Readiness Practicum and Professional Portfolio Development

Participate in a faculty led practicum by presenting components of the CRC Readiness Portfolio, including the study startup plan, recruitment strategy, informed consent workflow, regulatory documentation, source documentation, and visit workflow.

Participants will receive individualized coaching and feedback focused on operational readiness, communication skills, and demonstration of CRC competencies.

Practical Exercise Present and defend the CRC Readiness Portfolio.

Portfolio Deliverable Completed CRC Readiness Portfolio

Week 10

Career Development, Professional Identity, and Next Steps

Prepare for a successful transition into the clinical research workforce through resume and CV refinement, LinkedIn optimization, interview preparation, networking strategies, and professional certification planning.

Participants will also develop an individualized 90 day professional development plan to guide onboarding, competency development, certification, networking, and career advancement.

Practical Exercise Participate in a mock interview and career coaching session.

Portfolio Deliverable Career Readiness Package including Resume, LinkedIn Profile, Interview Preparation Materials, and 90 Day Professional Development Plan

Final Program Outcome

Graduates of the Clinical Research Coordinator Career Accelerator will leave the program with:

•
A Certificate of Completion
•
A comprehensive CRC Readiness Portfolio demonstrating practical clinical research competencies
•
Downloadable templates, checklists, and operational tools
•
Greater confidence entering Clinical Research Coordinator positions
•
A professional development plan for continued career growth and advancement

Faculty Director’s Bio:

Margret Kamel, PhD, CCRC

Study Start-Up Expert I Educator I Speaker at National & International Conferences

Margret Kamel, PhD, CCRC, is a seasoned clinical research leader and educator with over 15 years of experience in academic medicine and more than a decade leading complex, multi-center clinical trials. She currently serves as Director of Research Projects in the Division of Pediatric Nephrology at Emory University, where she oversees a diverse portfolio of industry-sponsored, NIH-funded, and investigator-initiated studies across the full clinical research lifecycle. Her work spans early feasibility through study closeout, with a focus on operational excellence, regulatory compliance, and high-quality data execution in pediatric and rare disease research.

Margret has extensive experience managing multi-site and consortium-based research, with significant leadership within the Pediatric Nephrology Research Consortium (PNRC), where she served as Co-Chair of the Coordinator Committee and continues to contribute to protocol review and research strategy. She has played a key role in advancing collaborative, multi-center studies and strengthening coordinator training and infrastructure across the network. Her work includes directing large-scale observational and interventional studies in pediatric nephrology, transplantation, and chronic kidney disease, while overseeing research operations, budgets exceeding $3 million annually, and cross-functional teams of coordinators, investigators, and institutional stakeholders. Her expertise includes study start-up and feasibility, clinical research finance and budgeting, regulatory strategy, data quality, and sponsor-site relationship management.

She holds a PhD in Health Promotion and Behavior with a concentration in health communication from the University of Georgia. Margret is a Certified Clinical Research Coordinator (CCRC) with extensive training in Good Clinical Practice and both biomedical and social behavioral research. Her academic and research contributions include numerous peer-reviewed publications and book chapters focused on pediatric kidney disease, transplantation outcomes, and health literacy.

In addition to her leadership in clinical research operations, Margret is an active contributor to national research and professional communities. She regularly presents at national and international conferences on topics including clinical trial management, health literacy, feasibility assessment, and research operations, and is recognized for her ability to bridge operational execution with strategic collaboration in multi-center research environments. Known for her collaborative leadership style and strategic approach, she is dedicated to advancing clinical research through strong teams, effective communication, and innovative operational models.