What is a Clinical Research Associate (CRA)?

A Clinical Research Associate (CRA) is a professional responsible for overseeing clinical trials to ensure they comply with protocols, ethical guidelines, and regulatory standards. CRAs play a crucial role in verifying data accuracy, monitoring trial sites, and ensuring the safety of participants while maintaining research integrity.

Why is becoming a Clinical Research Associate a good career choice?

Becoming a CRA offers competitive salaries, career stability, and the opportunity to contribute to groundbreaking advancements in medicine. This profession is in high demand, with roles in pharmaceutical companies, CROs, and academic institutions, making it an excellent choice for growth and global career opportunities.

What are the qualifications to become a Clinical Research Associate?

To qualify as a CRA, a bachelor's degree in life sciences, biology, pharmacology, or healthcare-related fields is typically required. Training programs, certifications such as those from CCRPS, ACRP, and SOCRA, and prior experience in clinical research or as a Clinical Research Coordinator (CRC) are also highly beneficial.

What is CRA certification, and is it necessary?

CRA certification is a professional credential demonstrating expertise in clinical trial monitoring, regulatory compliance, and Good Clinical Practice (GCP). While not always mandatory, certifications from organizations like CCRPS, ACRP, and SOCRA greatly enhance career prospects and validate a candidate’s skillset.

Which certifications are recognized for CRAs?

The most recognized certifications for CRAs include the CCRPS Certified Clinical Research Professionals Society certification, the ACRP Certified Clinical Research Associate (CCRA) credential, and the SOCRA Certified Clinical Research Professional (CCRP) certification. These programs validate proficiency in clinical research best practices.

What is a CRA training program?

CRA training programs are specifically designed to prepare individuals for the responsibilities of monitoring and managing clinical trials. These programs include topics such as clinical research certification, GCP standards, site auditing, regulatory compliance, and patient safety protocols.

Are online CRA training programs effective?

Yes, online CRA training programs are highly effective, offering self-paced learning to accommodate working professionals or individuals needing flexibility. Organizations like CCRPS provide comprehensive courses that cover clinical research associate certification, training modules, and industry-standard practices.

What career opportunities are available for Clinical Research Associates?

CRAs have opportunities to work in industries such as pharmaceuticals, biotechnology, CROs, and academic research institutions. With advanced experience and certifications, they can move up to positions like Clinical Trial Manager (CTM), Project Manager, and Clinical Monitoring Lead.

How much do CRAs earn on average?

On average, CRAs earn salaries ranging from $60,000 to $120,000 per year. Factors affecting salary include years of experience, certifications like CCRPS, ACRP, and SOCRA, and the hiring organization.

What topics are covered in CRA training programs?

Most CRA training programs cover clinical research certification, Good Clinical Practice (GCP) guidelines, regulatory compliance such as FDA and ICH requirements, adverse event reporting, clinical trial site audits, data management, and recruitment processes for clinical trials.

What is the difference between a CRA program and a clinical research certification?

A CRA program focuses on training aspiring CRAs, equipping them with professional knowledge to manage clinical trials. Clinical research certification validates an individual's expertise and competency in the clinical research field through exams and assessments provided by recognized organizations such as CCRPS, ACRP, and SOCRA.

What responsibilities do CRAs handle in clinical trials?

Clinical Research Associates ensure clinical trials comply with protocols, monitor trial sites for quality and data accuracy, verify informed consent, ensure participant safety, and manage investigational product accountability—all while adhering to GCP and regulatory requirements.

What key tools do Clinical Research Associates use?

CRAs use Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) platforms, and software for regulatory compliance to streamline data management, ensure site adherence to guidelines, and maintain trial efficiency.

What benefits do CRA certifications offer?

CRA certifications such as those from CCRPS, ACRP, and SOCRA demonstrate professional skill, increase earning potential, and open doors to leadership roles in clinical research. These certifications validate a candidate's ability to conduct and monitor trials according to industry standards.

Can CRA training programs help with career placement?

Yes, many CRA training programs, particularly those offered by CCRPS, provide career resources such as job placement support, resume-building advice, and internship opportunities to help students transition to clinical research roles.

Clinical Research Associate Certification I CRA Training

Clinical Research Associate Certification

Master CRA Skills in Just 4 Weeks I Advanced Clinical Research Associate Certification For CRCs, CTAs, Life Sciences Grads & Current CRAs | 288 Interactive Lessons | Live Webinars, 100s of Cases, Toolkits, Videos, MCQs, & More I 290Hr CPD + ACCRE + CE Accredited I 100% Online, Self-Paced | 8 Years of Alumni Success I Start Now or Call +1 (321) 273-7085 | 100% Money-Back Guarantee

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Clinical Research Associate Certification Tuition

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Clinical Research Associate Training

Dive into 288 Lessons for Our Advanced Clinical Research Associate Certification (ACRAC)

1. Clinical Research Associate Course Overview
  FREE PREVIEW
2. How to Use CRA Course / CME Handout
3. Common Terminology Used In Clinical Research - Reference Glossary
4. Commonly Used Abbreviations and Terms in Clinical Research
5. Live Review Session - See Discussion for Next Date
6. School Policy and Student Enrollment Agreement
1. Duties and Responsibilities of a Clinical Research Associate (CRA, Monitor)
  FREE PREVIEW
2. Introduction to Advanced Clinical Monitoring
3. Cross-functional Collaboration in Clinical Trials
4. Stakeholders in Clinical Trials (Sponsor, Project Manager, IRB, PI, CRA, CRC, Site Staff, Data Team/DSMB, Patients)
5. Ethical Considerations for Senior Monitors in Clinical Trials
6. Certification Goals for Advanced Clinical Monitors
7. Comprehensive Overview of ICH-GCP Principles for CRAs
8. Communication between Blinded and Unblinded Staff
9. Regional Guidelines for Clinical Trials
10. Sponsor, Investigator, and Institutional Review Board (IRB) Responsibilities
11. Contract Research Organizations (Delegation, Responsibilities, Management )
12. Legal and Ethical Standards in Clinical Research
13. Application of 21 CFR Part 11 in Clinical Trials
14. Future Trends in Clinical Monitoring for Clinical Research Associates
1. ICH GCP E6 Sections 2-4 Principles, IRB, & Investigator Roles
2. ICH GCP E6 Section 4 - Reporting Responsibilities of the Investigators
3. ICH GCP E6 Section 5 - Sponsor/CRO Responsibilities
1. Monitoring Procedures for Phases 0 to IV
2. Challenges in Translational Research
3. Safety Compliance in Clinical Trials
4. Protocol-Specific Monitoring Techniques
5. Applications in Clinical Monitoring
6. Monitoring in Pediatric Trials
7. Monitoring in Vulnerable Population Trials
1. Advanced Designs of Clinical Trials
2. Advanced Review of Phases of Clinical Trials (Preclinical & Phase 0-4)
3. Randomized Controlled Trials (Randomization, Allocation Concealment, Validity, Blinding, Controls, Outcomes, Fidelity)
4. Blinding and Unblinding in Clinical Trials
1. An Introduction to Clinical Research
2. An Overview of ICH GCP
3. Ethics of Research Involving Children
1. The Clinical Trial Protocol - Advanced Mastery Review
2. Inclusion and Exclusion Criteria in Clinical Research (Writing, Assessing for Broad vs. Narrow, Organ Dysfunction, Older Adults, Pediatrics, Pregnant Women)
1. Advanced Review of Adverse Events
1. Protocol Deviations and Violations (Major, Minor, Exceptions, Resolution)
1. Institutional Review Board/Ethics Committee (IRB/EC) (Requirements, sIRB, Application, Exemptions, Expedited Review, Continuation, and Reporting)
2. Data Safety Monitoring board- DSMB
1. Types of Monitoring Visits (Selection, Initiation, Routine, Close-Out)
1. Site and Investigator Selection Criteria (Process, Criteria, Investigator Selection, Agreements, Decision-Making)
2. Site Selection/Qualification Pre-Study Visit (SSV/SQV) (Before, During, After, Letters, Checklists, and Report)
1. Site Initiation Visit (SIV) (Before, During, After, Letters, Checklists, and Report) - Review from "Types of Monitoring Visits"
1. Routine/Interim/Periodic Monitoring Visit (RMV/IMV/PMV) (Before, During, After, Remote, Letters, Checklists, and Report)
1. Site Close Out Visit (Before, During, After, Early Termination, Letters, Checklists, and Report)
1. Monitoring Tools and Softskills (Tools, Templates, Communication, Metrics, Motivation, Humanistic Qualities)
2. Develop Templates for Monitoring Visits (Site Preparation, Pre-visit Letter/Agenda, Visit Checklist, Followup Letter, Visit Report)
1. Audits and Inspections in Clinical Trials
2. FDA Bioresearch Monitoring Program (BIMO)
3. FDA Warning Letter
1. ICH GCP Section 4.8 Informed Consent
2. Source Documents and Informed Consent Forms (SDV Checklist, Informed Consent Checklist)
3. Minimizing Source Data Queries In Clinical Trials
1. Guidelines for Designing and Completing Case Report Forms
2. Do’s and Don’ts of a Case Report Form Design
1. Quality Control in Clinical Trials ( QC/QA, KQI, QMS, Checklist)
2. ICH GCP - Safety of Human Subjects in Clinical Research
1. ICH GCP - Trial Management, Data Handling, and Record Keeping
2. Interactive Response Technologies in Clinical Trials (IVRS, IWRS, IRT, RTSM)
3. Clinical Trial Management System-CTMS
4. Electronic Data Capture and Remote Data Capture Basics
5. Electronic Regulatory Submission and Review
1. An Overview of Remote Monitoring - COVID-19 Update
2. Remote Monitoring of Clinical Trials and EMRs
3. Centralized Monitoring
1. Advanced Practice of Pharmacovigilance
2. Regulatory Affairs for Clinical Trials
1. Investigational Product Storage and Dispensing
2. Investigational Product Accountability in Clinical Trials
1. Developing Monitoring Plans
2. Risk-Based Monitoring Implementation
3. Adaptive Monitoring Techniques
4. Predictive Analytics in Monitoring
5. Tools for Source Data Verification
6. Conducting Centralized Monitoring
7. Conducting On-Site Monitoring in Clinical Trials
8. Site Selection Procedures in Clinical Trials
9. Feasibility Assessment in Clinical Trials
1. Local and Central Labs in Clinical Trials (Local, Regional, Central, GLCP, CLIA Cert, Lab Audit Checklist)
1. Regulatory Documents in Clinical Trials
2. Delegation of Authority Log – DOAL
3. Investigators Brochure (IB)
1. Monitoring Oncology Trials
2. Monitoring Rare Disease Trials
3. Monitoring Device Trials
4. Monitoring Drug Trials
5. Multi-National Trial Coordination for Clinical Research Associates
1. Code of Federal Regulations
2. CFR 21 Part 11
1. The Investigational New Drug (IND) & New Drug Application (NDA) Process
2. Investigator Initiated Multi-Center Trials
3. IND and IDE AE Reporting
4. Safety Reporting Requirements for Sponsor Investigators of An IND
1. Essential Regulatory Documents Binder Tab Organization (Trial Master File)
2. Trial Master File Reference Guide
3. Regulatory Training Quiz
1. Financial Disclosure- Duties and Strategies for Clinical Studies
2. Payments and Budgeting for Investigators and Site
3. Advertisement Aid in Subject Recruitment and Retention
1. Patient Recruitment in Clinical Trials
2. Patient Engagement and Retention in Clinical Trials
3. Patient Adherence and Compliance in Clinical Trials
1. Scientific Misconduct and Fraud
2. Detecting Falsification
1. SQV Checklist
2. SQV Questionnaire
3. SQV Assessment
4. SQV Follow Up Letter
5. SIV Agenda
6. SIV Confirmation Letter
7. SIV Report
8. RMV Confirmation Letter/Fax
9. RMV Report
10. RMV Follow Up Letter
11. CRA TRANSITION Letter/Email/Fax
12. SCOV Confirmation Letter
13. SCOV Agenda
14. SCOV Report
15. SCOV Follow Up Letter
16. REFERENCE Module
1. Investigator Qualification and Training
2. Ensuring Protocol Adherence in Clinical Trials
3. Managing Non-compliance in Clinical Trials
4. Developing CAPA Plans for Clinical Research Associates
5. Oversight During Site Initiation
6. Site Maintenance and Closure Procedures
1. Ensuring Data Accuracy and Reliability
2. Handling Missing Data in Trials
3. Developing Risk Management Plans in Clinical Trials
4. Statistical Tools for Risk Assessment in Clinical Trials
5. Identifying High-risk Sites for Clinical Research Associates
6. Reshaping Monitoring Activities in Clinical Trials
1. Adverse Event Reporting
2. Signal Detection Tools
3. Signal Management in Clinical Trials
4. Communicating Safety Outcomes
5. Proactive Risk Mitigation Plans for Clinical Research Associates
1. Machine Learning Applications in Monitoring
2. Visual Reporting Dashboards
3. Digital Error Detection Tools
4. Introduction to A-B Split Testing
5. Sequential Techniques in Monitoring
1. Managing Cross-Functional Teams
2. Leadership in Decision Making
3. Negotiating With Sponsors in Clinical Trials
4. Addressing Stakeholders’ Needs
1. Real-world Monitoring Simulation Exercises
2. Case Study Analysis in Monitoring
3. Senior Medical Monitor Requirements
1. Advanced Data Management Techniques
2. Clinical Trial Budgeting for Clinical Research Associates
3. Regulatory Submission Processes
4. Pharmacovigilance Strategies
5. Crisis Management in Clinical Trials
6. Advanced Biostatistics for Monitors
7. Cross-Cultural Communication
8. Project Management in Clinical Trials
1. Advanced Patient Recruitment Techniques
2. Advanced Lecture on Advanced Site Management Techniques
3. Advanced Protocol Development for Clinical Research Associates
4. Advanced Risk Assessment for Clinical Research Associates
5. Advanced Compliance Monitoring in Clinical Trials
6. Advanced Investigator Training for Clinical Research Associates
7. Advanced Monitoring Technologies in Clinical Trials
8. Advanced Data Analysis Techniques
9. Advanced Safety Monitoring for Clinical Research Associates
10. Ethical Considerations in Advanced Monitoring
11. Advanced Trial Design and Implementation
1. Monitoring Digital Health Technologies
2. Monitoring Biologics Trials
3. Monitoring Gene Therapy Trials
4. Monitoring Vaccine Trials for Clinical Research Associates
5. Monitoring Rare Disease Trials
6. Monitoring Pediatric Trials
7. Monitoring Oncology Trials
8. Monitoring Neurology Trials
9. Monitoring Infectious Disease Trials
10. Monitoring Endocrinology Trials
11. Monitoring Gastroenterology Trials
12. Monitoring Dermatology Trials
13. Monitoring Respiratory Trials
14. Monitoring Ophthalmology Trials
15. Monitoring Ophthalmology Trials for Clinical Research Associates
16. Monitoring Rheumatology Trials
17. Monitoring Urology Trials
18. Monitoring Nephrology Trials
19. Monitoring Hematology Trials
20. Monitoring Psychiatry Trials
21. Monitoring Women's Health Trials for Clinical Research Associates
22. Monitoring Men’s Health Trials
23. Monitoring Geriatric Trials
24. Monitoring Genetic Trials
25. Monitoring Nutritional Trials
26. Monitoring Behavioral Trials for Clinical Research Associates
27. Monitoring Surgical Trials
28. Monitoring Device Trials
29. Monitoring Combination Trials
30. Monitoring Nutritional Trials
31. Monitoring Adaptive Trials
32. Monitoring Basket Trials for Clinical Research Associates
33. Monitoring Umbrella Trials
34. Monitoring Platform Trials
35. Monitoring Pragmatic Trials
36. Monitoring Observational Trials
37. Monitoring Registry Trials
38. Monitoring Expanded Access Trials for Clinical Research Associates
39. Monitoring Compassionate Use Trials
40. Monitoring Investigator-Initiated Trials
41. Monitoring Industry-Sponsored Trials
42. Monitoring Government-Sponsored Trials
43. Monitoring Academic Trials
44. Monitoring Collaborative Trials for Clinical Research Associates
45. Monitoring International Trials
46. Monitoring Multicenter Trials
47. Monitoring Single-Center Trials
1. Monitoring Phase 0 Trials
2. Monitoring Phase I Trials
3. Monitoring Phase II Trials
4. Monitoring Phase III Trials
5. Monitoring Phase IV Trials
6. Monitoring Post-Marketing Trials
1. Monitoring Pharmacokinetic Trials
2. Monitoring Pharmacodynamic Trials
3. Monitoring Bioequivalence Trials for Clinical Research Associates
4. Monitoring Bioavailability Trials
1. Monitoring Drug-Drug Interaction Trials
2. Monitoring Drug-Food Interaction Trials
3. Monitoring Drug-Alcohol Interaction Trials
4. Monitoring Drug-Tobacco Interaction Trials
5. Monitoring Drug-Caffeine Interaction Trials for Clinical Research Associates
6. Monitoring Drug-Herb Interaction Trials
7. Monitoring Drug-Disease Interaction Trials
8. Monitoring Drug-Genotype Interaction Trials
9. Monitoring Drug-Phenotype Interaction Trials
10. Monitoring Drug-Environment Interaction Trials for Clinical Research Associates
11. Monitoring Drug-Lifestyle Interaction Trials
12. Monitoring Drug-Behavior Interaction Trials
13. Monitoring Drug-Compliance Interaction Trials
14. Monitoring Drug-Adherence Interaction Trials
15. Monitoring Drug-Persistence Interaction Trials for Clinical Research Associates
16. Monitoring Drug-Switching Interaction Trials
17. Monitoring Drug-Substitution Interaction Trials
18. Monitoring Drug-Combination Interaction Trials
19. Monitoring Drug-Sequence Interaction Trials
20. Monitoring Drug-Dose Interaction Trials
21. Monitoring Drug-Route Interaction Trials
22. Monitoring Drug-Formulation Interaction Trials
23. Monitoring Drug-Release Interaction Trials
24. Monitoring Drug-Absorption Interaction Trials
25. Monitoring Drug-Distribution Interaction Trials
26. Monitoring Drug-Metabolism Interaction Trials
27. Monitoring Drug-Excretion Interaction Trials
28. Monitoring Drug-Transport Interaction Trials
29. Monitoring Drug-Receptor Interaction Trials
30. Monitoring Drug-Enzyme Interaction Trials
31. Monitoring Drug-Ion Channel Interaction Trials
32. Monitoring Drug-Transporter Interaction Trials for Clinical Research Associates
33. Monitoring Drug-Protein Interaction Trials
34. Monitoring Drug-DNA Interaction Trials
35. Monitoring Drug-RNA Interaction Trials
36. Monitoring Drug-Enzyme Interaction Trials
37. Monitoring Drug-Lipid Interaction Trials
38. Monitoring Drug-Lipid Interaction Trials
39. Monitoring Drug-Carbohydrate Interaction Trials
40. Monitoring Drug-Vitamin Interaction Trials
41. Monitoring Drug-Mineral Interaction Trials
42. Monitoring Drug-Amino Acid Interaction Trials
43. Monitoring Drug-Peptide Interaction Trials
44. Monitoring Drug-Protein Complex Interaction Trials
45. Monitoring Drug-Cell Interaction Trials
46. Monitoring Drug-Tissue Interaction Trials
47. Monitoring Drug-Organ Interaction Trials
48. Monitoring Drug-System Interaction Trials
49. Monitoring Drug-Organism Interaction Trials
50. Monitoring Drug-Population Interaction Trials
51. Monitoring Drug-Community Interaction Trials
52. Monitoring Drug-Ecosystem Interaction Trials
1. Conceptual Frameworks in Clinical Monitoring
2. Theoretical Models in Clinical Research
3. Advanced Monitoring Methodologies
4. Innovative Monitoring Strategies
1. CRA Certification Exam Study Guide
2. ACRAC Certification Exam (50 Questions)

CRA Training

$495.00
287 lessons
CPD, CME, & ACCRE Accredited.
Required 4 Year Science Degree or Prior CRC.
1 in 5 alumni landed managerial roles within 4 years.

a fundamental stepping stone for all monitors

george grudziak

If you want to move up the ladder in clinical trials, this is the best course to take. It’s so affordable even though I’ve paid three times as much to learn what is covered in just a chapter. I refer back to the course every time I switch to a new...

Provider / Course	Core Offering & Credentials	Price + Renewal & Key Pros / Cons
CCRPS – ACRAC™ Advanced Clinical Research Associate Certification	• 288 modules • 290 CPD hours • Triple-accredited (CPD, CME, ACCRE) • Live webinars, 1:1 mentoring, and real-world protocol simulations • 600+ scenario-based MCQs • 100+ case simulations for CRA practice • Downloadable study guide + 50-question certification exam • Digital certificate + LinkedIn badge • Lifetime access	$485 Pros: most advanced and comprehensive CRA training globally; built for CRCs, CTAs, or transitioning researchers; includes GCP, SDV, RBM, and decentralized trial operations; extensive practice bank and simulation labs; lifetime updates; 14-day refund Cons: in-depth curriculum may require more time commitment
Academic CRA Program	• 6–8 week certificate • Recorded lectures + discussion forums • Focus on site operations and trial documentation	$1,800–$2,500 Pros: academic oversight; discussion-driven Cons: no CPD/CME; limited mentoring or real-world simulations; higher cost
Association CRA Exam-Only Credential	• Self-study exam (100 MCQs) • Valid 3 years (retest or CE for renewal) • Exam center-based in some cases	$395–$550 Pros: fast certification; globally recognized credential Cons: no course content, no live support, no feedback or training included
Vendor CRA Micro-Credential	• 3–5 hour micro-course • Basic GCP/ICH principles • Digital badge (non-certification)	$149–$299 Pros: quick refresher or intro; entry-level recognition Cons: not accredited; no credential portability or hiring impact

ACRAC Grad Results	Details
ACRAC Certification Overview	• Online certificate + LinkedIn badge issued immediately after passing• Competency exam: 50 scenario-based MCQs• Passing threshold: 70% (two attempts included)
ACRAC Grads Landed Job Roles At	Moderna · Merck · IQVIA · ICON plc · Eli Lilly and Company · AstraZeneca · VaxTrials · Deloitte · Procter & Gamble · Novotech · St. Jude Children’s · Mount Sinai · U.S. DOH HHS · Mass General Hospital · HCA Hospital · Janssen Pharma (J&J) · Tulane University · Memorial Sloan Kettering Cancer Center · Stanford University · University of Miami · University of Alberta · eClinicalWorks
Job Titles ACRAC Grads Earned After Date Of Course Enrollment	Clinical Research Associate · Clinical Trial Monitor II · Research Associate · CRA II · Scientist · Quality Assurance Analyst · Senior Clinical Research Associate · Research Associate in Discovery Immunology · Clinical Trial Monitor / CRA · Clinical Trials Project Manager · Associate Director of Research Nursing · Clinical Trial Navigator · Clinical Director for R&D · Clinical Research Professional · Medical Science Liaison · Clinical Trial Associate III · Quality Assurance Associate II · IRB/SRC Analyst II · Project Manager · Clinical Trial Associate · Clinical Research Coordinator · Public Health Advisor · Associate Scientist II · Strategy Analyst · Clinical Research Associate II · Clinical Operations Specialist · Advisor - Development Clinical Research Scientist, Neuroscience · Associate Clinical Engineer · Clinical Trial Management Associate · Quality Supervisor · Clinical Research Data Coordinator

Chapter & Lessons	Detailed Objectives & Skills
CH 1. Foundations of Advanced Clinical Monitoring: Duties & Responsibilities of a CRA, Introduction to Advanced Clinical Monitoring, Cross‑functional Collaboration, Stakeholders in Clinical Trials, Ethical Considerations for Senior Monitors, Certification Goals, ICH‑GCP Principles for CRAs, Blinded vs. Unblinded Communication, Regional Guidelines, Sponsor/Investigator/IRB Responsibilities, CRO Management, Legal & Ethical Standards, 21 CFR Part 11, Future Trends	• Define the CRA role and monitor responsibilities across all trial phases • Facilitate collaboration among sponsors, IRBs, investigators, CRCs, data teams, and patients • Apply senior‑monitor ethical frameworks to ensure subject welfare and data integrity • Interpret and implement ICH‑GCP E6 requirements for monitoring activities • Distinguish communication protocols for blinded vs. unblinded staff to maintain trial validity • Navigate regional regulatory variations and 21 CFR Part 11 compliance for electronic records • Assess emerging monitoring trends and technologies
CH 2. Sponsor & Investigator Roles: ICH GCP E6 Sections 2–4 (Principles, IRB, Investigator Roles), Section 4 (Reporting), Section 5 (Sponsor/CRO Responsibilities)	• Analyze ICH GCP E6 responsibilities: sponsor, investigator, IRB interactions • Draft and review investigator reporting plans per Section 4 and Section 5 • Establish oversight mechanisms to ensure sponsor and CRO obligations are met • Coordinate regulatory submissions and safety-reporting workflows
CH 3. Clinical Trial Phases & Procedures: Monitoring Procedures Phases 0–IV, Translational Research Challenges, Safety Compliance, Protocol‑Specific Monitoring, Pediatric & Vulnerable Population Trials	• Design and execute phase‑appropriate monitoring plans—from preclinical through post‑marketing • Identify and mitigate translational‑research risks • Implement safety‑compliance audits and real‑time issue escalation • Tailor monitoring techniques for pediatric and other vulnerable cohorts
CH 4. Clinical Trial Design: Advanced Trial Designs, Preclinical & Phases 0–IV Review, Randomized Controlled Trials (Randomization, Allocation Concealment, Blinding), Blinding & Unblinding	• Critique advanced and adaptive trial designs for scientific rigor and feasibility • Develop and validate randomization schemes and emergency unblinding procedures • Ensure integrity of control groups and outcome assessments through robust masking strategies
CH 5. ICH GCP Overview: Introduction to Clinical Research, ICH GCP Fundamentals, Ethics of Research Involving Children	• Summarize ICH GCP history and core principles • Apply ethical guidelines for pediatric research, including assent and parental consent
CH 6. Adverse Events: Advanced Review of Adverse Events	• Classify and grade adverse events using CTCAE scales • Manage reporting timelines and causality assessments per E2A requirements
CH 7. Clinical Trial Protocol: Advanced Mastery Review, Inclusion/Exclusion Criteria for Special Populations	• Critically evaluate protocol objectives, endpoints, and statistical plans • Craft precise eligibility criteria for geriatric, pediatric, and pregnant cohorts • Maintain version control and amendment workflows
CH 8. Protocol Deviations & Violations: Major/Minor Deviations, Exceptions, Resolution	• Identify, categorize, and document deviations and violations • Implement root‑cause analyses and corrective‑action plans to prevent recurrence
CH 9. IRB & DSMB: IRB/EC Requirements, sIRB Processes, Exemptions & Expedited Reviews, DSMB Operations	• Prepare and submit IRB/EC applications, amendments, and continuing‑review documents • Coordinate DSMB charters, data‑freeze packages, and safety‑monitoring reports
CH 10. Site Monitoring Visits: Selection, Initiation, Routine, Close‑Out Visits	• Plan and conduct pre‑visit, on‑site, and post‑visit activities for all visit types • Use standardized letters, checklists, and visit reports to document compliance
CH 11. Site Qualification Visit (SQV): Selection Criteria, SSV/SQV Procedures (Before, During, After), Letters, Checklists, Reports	• Assess site infrastructure, staff qualifications, and regulatory readiness • Compile SQV reports and remedial action plans
CH 12. Site Initiation Visit (SIV): SIV (Before, During, After), Letters, Checklists, Reports	• Execute SIV preparations: regulatory file review, informed‑consent training, IP handling • Produce SIV deliverables to ensure site activation readiness
CH 13. Routine/Interim/Periodic Monitoring Visits: RMV/IMV/PMV (Before, During, After, Remote), Letters, Checklists, Reports	• Implement risk‑based scheduling for routine and remote monitoring • Leverage central‑monitoring data to optimize on‑site visit frequency
CH 14. Site Close‑Out Visit (SCOV): Early Termination Procedures, Letters, Checklists, Reports	• Coordinate close‑out logistics: IP reconciliation, regulatory file archival, data query resolution
CH 15. Monitoring Tools & Soft Skills: Tools, Templates, Communication, Metrics, Motivation, Humanistic Qualities; Develop Visit Templates	• Design monitoring templates: agendas, checklists, and follow‑up reports • Cultivate active listening, conflict‑resolution, and motivational techniques to build site rapport
CH 16. Audits & Inspections: FDA BIMO Program, Warning Letters, Inspection Readiness	• Conduct mock audits and regulatory inspections • Draft responses to FDA Warning Letters and manage CAPA implementations
CH 17. SDV & Informed Consent: ICH GCP Section 4.8, SDV & ICF Checklists, Query Minimization	• Validate source‑data verification processes and minimize query volume • Ensure informed‑consent compliance and audit‑trail completeness
CH 18. Case Report Form Design: CRF Guidelines, Do’s & Don’ts	• Develop user‑friendly CRFs with built‑in edit checks and annotation conventions • Align CRF fields with protocol‑specified data requirements
CH 19. Quality Control & Safety: QC/QA, KQI, QMS, Safety of Human Subjects	• Implement quality‑management frameworks and key‑quality indicators • Monitor human‑subject safety through real‑time safety dashboards
CH 20. Trial Technology: IRT (IVRS/IWRS/RTSM), CTMS, EDC & Remote Data Capture, Electronic Regulatory Submissions	• Configure and validate electronic systems for randomization, supply management, and data capture • Manage e‑submissions in compliance with regulatory standards
CH 21. Modernized Monitoring: Remote, Risk‑Based, Centralized (COVID‑19 Updates)	• Adopt remote‑monitoring platforms and EMR integrations • Apply centralized statistical monitoring to identify site anomalies
CH 22. Pharmacovigilance & Regulatory Affairs: Advanced PV Practices, Regulatory Affairs	• Establish pharmacovigilance workflows for signal detection and risk management • Coordinate regulatory submissions and labeling updates
CH 23. Investigational Product Management: Storage, Dispensing, Accountability	• Ensure IP chain‑of‑identity and temperature‑controlled logistics • Maintain IP accountability logs and reconciliation procedures
CH 24. Monitoring Techniques & Tools: Monitoring Plan Development, Adaptive & Risk‑Based Techniques, Predictive Analytics, Centralized & On‑Site Monitoring, Feasibility Assessments	• Draft comprehensive monitoring plans incorporating adaptive triggers • Use predictive‑analytics tools to prioritize high‑risk sites • Conduct feasibility assessments to inform site selection
CH 25. Local & Central Laboratories: GLP/CLIA Compliance, Lab Audit Checklists	• Audit lab partners for regulatory compliance • Coordinate sample logistics between local, regional, and central labs
CH 26. Regulatory Documents: TMF Management, DOAL, Investigator’s Brochure	• Organize and maintain Trial Master File binders per DIA standards • Manage delegation logs and IB updates
CH 27. Specialized Monitoring Areas: Oncology, Rare Disease, Device, Drug Trials, Multi‑National Coordination	• Adapt monitoring for therapeutic‑area specifics and cross‑border regulatory requirements • Manage complex logistics for multi‑center and international studies
CH 28. CFR 21 Part 11 – Electronic Signatures: Code of Federal Regulations, Part 11	• Validate electronic‑signature systems and audit trails • Ensure user‑access controls and data‑integrity checks align with CFR Part 11
CH 29. IND & NDA Processes: IND & NDA Submission, Investigator‑Initiated Trials, AE Reporting for IND/IDE	• Draft and review IND/NDA applications with safety‑reporting annexures • Oversee AE reporting requirements for sponsor investigators
CH 30. Trial Master File: Binder Tab Organization, TMF Reference Guide, Regulatory Training	• Implement best practices for TMF organization and retrieval • Conduct TMF‑compliance training and audits
CH 31. Financial Disclosures & Payments: Disclosure Strategies, Site/Investigator Budgets, Recruitment Advertising	• Manage financial‑disclosure processes for PIs and sites • Develop investigator payment schedules and site‑budget worksheets • Create compliant recruitment‑advertising materials
CH 32. Patient Recruitment & Compliance: Recruitment Strategies, Engagement & Retention, Adherence Monitoring	• Leverage digital and community‑outreach tactics for recruitment • Implement adherence‑support programs (reminders, home visits) • Analyze retention metrics to refine engagement plans
CH 33. Misconduct & Fraud: Scientific Misconduct, Fraud Detection	• Identify red flags in data and documentation • Perform forensic‑audit techniques to detect falsification
CH 34. Site Visit Templates: SQV, SIV, RMV, SCOV Checklists & Letters, CRA Transition Templates	• Customize and deploy comprehensive visit and transition templates • Standardize document format and version control
CH 35. Investigator & Site Management: Qualification, Training, Protocol Adherence, CAPA Plans, Site Maintenance	• Conduct investigator‑qualification training and monitoring • Develop CAPA plans for non‑compliance • Manage site‑maintenance and closure workflows
CH 36. Data Management & Risk Assessment: Data Accuracy, Missing Data Handling, Risk Plans, Statistical Risk Tools, High‑Risk Site Identification	• Implement data‑cleaning SOPs and discrepancy‑resolution workflows • Use statistical tools (e.g., control charts) to assess site‑risk profiles • Develop and execute trial‑wide risk‑management plans
CH 37. Safety & Signal Management: AE Reporting, Signal Detection Tools, Safety Communication, Proactive Mitigation	• Deploy signal‑detection algorithms and dashboards • Coordinate safety‑outcome communications with sponsors and regulators • Implement risk‑mitigation plans for emerging safety signals
CH 38. Technology & Innovation in Monitoring: ML Applications, Reporting Dashboards, Digital Error Detection, A/B Testing, Sequential Techniques	• Integrate machine‑learning models for anomaly detection • Build interactive dashboards for real‑time monitoring metrics • Design A/B and sequential‑monitoring experiments to optimize processes
CH 39. Leadership & Team Management: Cross‑Functional Team Leadership, Decision‑Making, Sponsor Negotiations, Stakeholder Engagement	• Lead multi‑disciplinary teams with situational leadership styles • Negotiate site and vendor contracts • Address stakeholder needs through structured communication frameworks
CH 40. Practical Applications & Certification: Monitoring Simulations, Case Studies, Senior Medical Monitor Requirements	• Execute end‑to‑end monitoring simulations and debriefs • Analyze complex case studies to reinforce best practices • Prepare for senior‑monitor certification standards
CH 41. Advanced Data & Project Management: Advanced Data Techniques, Budgeting, Regulatory Submissions, PV Strategies, Crisis Management, Biostatistics, Cross‑Cultural Communication, Project Management	• Manage large‑scale data‑sets with advanced cleaning and visualization techniques • Develop clinical‑trial budgets and resource‑allocation plans • Lead crisis‑management responses for safety or compliance events
CH 42. Advanced Monitoring Strategies: Patient Recruitment, Site Management, Protocol Development, Risk Assessment, Compliance Monitoring, Investigator Training, Monitoring Technologies, Data Analysis, Safety Monitoring, Ethical Considerations, Advanced Trial Design	• Synthesize advanced recruitment and site‑management tactics • Design and implement complex protocol and monitoring frameworks • Apply ethical principles in high‑risk and adaptive trials
CH 43. Specialized Monitoring Techniques: Digital Health, Biologics, Gene Therapy, Vaccine, Rare Diseases, Pediatric, Oncology, Neurology, Infectious Disease, Endocrinology, Gastroenterology, Dermatology, Respiratory, Ophthalmology, Rheumatology, Urology, Nephrology, Hematology, Psychiatry, Women’s & Men’s Health, Geriatric, Genetic, Nutritional, Behavioral, Surgical, Device, Combination, Adaptive, Basket, Umbrella, Platform, Pragmatic, Observational, Registry, Expanded Access, Compassionate Use, Investigator‑Initiated, Industry/Government/Academic, Collaborative, International, Multicenter, Single‑Center	• Adapt monitoring plans to a diverse array of trial modalities and therapeutic areas • Coordinate specialty‑trial logistics, regulatory submissions, and site training for each modality
CH 44. Phase‑Specific Monitoring: Phase 0–IV & Post‑Marketing Trials	• Implement phase‑tailored monitoring checklists and safety‑reporting protocols
CH 45. Pharmacokinetics & Dynamics Trials: Bioequivalence, Bioavailability	• Oversee PK/PD sampling plans, assay validation, and data‑interpretation guidelines
CH 46. Drug Interaction Monitoring: Drug‑Drug, Drug‑Food, Drug‑Alcohol, Drug‑Tobacco, Drug‑Caffeine, Drug‑Herb, Drug‑Disease, Drug‑Genotype, Drug‑Phenotype, Drug‑Environment, Drug‑Lifestyle, Drug‑Behavior, Drug‑Compliance, Drug‑Adherence, Drug‑Persistence, Drug‑Switching, Drug‑Substitution, Drug‑Combination, Drug‑Sequence, Drug‑Dose, Drug‑Route, Drug‑Formulation, Drug‑Release, Drug‑Absorption, Drug‑Distribution, Drug‑Metabolism, Drug‑Excretion, Drug‑Transport, Drug‑Receptor, Drug‑Enzyme, Drug‑Ion Channel, Drug‑Transporter, Drug‑Protein, Drug‑DNA, Drug‑RNA, Drug‑Lipid, Drug‑Carbohydrate, Drug‑Vitamin, Drug‑Mineral, Drug‑Amino Acid, Drug‑Peptide, Drug‑Cell, Drug‑Tissue, Drug‑Organ, Drug‑System, Drug‑Organism, Drug‑Population, Drug‑Community, Drug‑Ecosystem	• Design and manage interaction‑study protocols: sample timing, crossover designs, and wash‑out periods • Analyze interaction data for clinical significance and regulatory reporting
CH 47. Advanced Theoretical Monitoring Concepts: Conceptual Frameworks, Theoretical Models, Innovative Strategies	• Evaluate and apply conceptual models (e.g., risk‑based quality management) • Develop novel monitoring strategies grounded in theoretical research
Final Examination & Certification: CRA Certification Exam Study Guide, ACRAC Exam (50 Questions)	• Synthesize comprehensive monitoring knowledge in exam format • Demonstrate readiness for ACRAC certification through targeted review and practice questions

$495.00

3 x $500

$1,500.00

Introduction

CH 1. Wk 1 Foundations of Advanced Clinical Monitoring

CH 2. Wk 1 Sponsor and Investigator Roles

CH 3. Wk 1 Clinical Trial Phases and Procedures

CH 4. Wk 1 Clinical Trial Design

CH 5. Wk 1 ICH GCP - Overview

CH 7. Wk 1 Clinical Trial Protocol

CH 6. Wk 1 Adverse Events

CH 8. Wk 1 Protocol Deviations and Violations

CH 9. Wk 1 IRB and DSMB

CH 10. Wk 1 Site Monitoring Visits

CH 11. Wk 1 Site Qualification Visit (SQV)

CH 12. Wk 1 Site Initiation Visit (SIV)

CH 13. Wk 2 Routine Monitoring Visit (RMV)

CH 14. Wk 2 Site Close-Out Visit (SCOV)

CH 15. Wk 2 Tools for Monitoring Visits

CH 16. Wk 2 Audit and Inspections

CH 17. Wk 2 SDV and Informed Consent

CH 18. Wk 2 Case Report Form

CH 19. Wk 2 Quality Control and Safety

CH 20. Wk 2 Technology in Trials (IVRS, CTMS, EDC)

CH 21. Wk 2 Modernized Monitoring (Remote, Risk-based, Centralized)

CH 22. Wk 2 Pharmacovigilance and Regulatory Affairs

CH 23. Wk 2 Investigational Product

CH 24. Wk 2 Monitoring Techniques and Tools

CH 25. Wk 2 Local and Central Labs

CH 26. Wk 2 Regulatory Documents

CH 27. Wk 3 Specialized Monitoring Areas

CH 28. Wk 3 CFR 21 Part 11 - Electronic Signatures

CH 29. Wk 3 New Drug Application

CH 30. Wk 3 Trial Master File

CH 31. Wk 3 Disclosures and Payments for PI, Site, Patients

CH 32. Wk 3 Patient Recruitment, Retention, and Compliance

CH 33. Wk 3 Misconduct and Fraud

CH 34. Wk 3 Site Visit Templates

CH 35. Wk 3 Investigator and Site Management

CH 36. Wk 3 Data Management and Risk Assessment

CH 37. Wk 3 Safety and Signal Management

CH 38. Wk 3 Technology and Innovation in Monitoring

CH 39. Wk 3 Leadership and Team Management

CH 40. Wk 4 Practical Applications and Certification

CH 41. Wk 4 Advanced Data and Project Management

CH 42. Wk 4 Advanced Monitoring Strategies

CH 43. Wk 4 Specialized Monitoring Techniques

CH 44. Wk 4 Phase-Specific Monitoring

CH 45. Wk 4 Pharmacokinetics and Dynamics

CH 46. Wk 4 Drug Interaction Monitoring

CH 47. Wk 4 Advanced Theoretical Monitoring Concepts

Final Examination

CRA Training

$495.00

3 x $500

$1,500.00

What does clinical research associate certification involve and why should I pursue it?

How do I become a certified clinical research associate with real job-readiness?

What kind of clinical research associate training does ACRAC offer?

Can CRA clinical research associate certification help me land my first CRA job?

What should I expect from a comprehensive clinical research associate training program?

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Why is the ACRAC clinical research associate program considered best-in-class?

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What sets clinical research associate programs like ACRAC apart from degrees?

What’s included in ACRAC that typical CRA certification programs miss?

Is this CRA program suitable for international candidates?

Will I receive a clinical research associate certificate immediately after completing the exam?

How long does it take to finish this clinical research associate training program?

Are mentorship and career coaching included?

How does ACRAC prepare me for clinical trial site audits?

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What kind of exam does ACRAC include?