🎓 Clinical Research & Trials Certification Programs

Offered by Qtech-Sol Professional Development Center

🔹 Introduction

Clinical Research is essential to the discovery, testing, and approval of new medical treatments and therapies. As the demand for safe and effective healthcare solutions grows globally, so does the need for skilled professionals in clinical operations, site coordination, monitoring, and study management.

Qtech-Sol offers structured, role-based certification programs designed for students, career changers, and working professionals seeking to enter or advance in the clinical trials industry. Programs emphasize simulation-based learning and career readiness for roles from entry-level to advanced project leadership.

🌟 Best-Fit Program Finder

At Qtech-Sol Professional Development Center, we know every learner’s journey is unique. That’s why we’ve built this Best-Fit Program Finder to match your education, experience, and career goals with the right training program.

Whether you’re a student, career changer, or working professional, our tool helps you quickly discover the program best suited to your background.

🔹 Option A — Manual Filters
Select your Education Major, Level, Experience, Student Category, and Domain from the dropdowns, then click Show Programs to see your best-fit training options.

🔹 Option B — Resume Parse
Paste or upload your resume (Word/PDF), and our AI parser will extract your details to recommend the most relevant programs. Click Parse & Recommend to view suggestions.

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🔹 Available Certification Programs

1. Clinical Trial Assistant (CTA — Support Level)

  • Level: Support-level (Diploma, BSc)
  • Duration: 5 weeks / 130 hours
  • Curriculum:
    • Intro to clinical trial phases & stakeholders
    • Regulatory & site documentation fundamentals
    • Investigator meeting prep & logistics
    • Tracking TMF documents, logs, correspondence
    • Communication follow-ups & status reporting
  • Format: LMS lessons, mock docs/logs, interactive checks

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2. Clinical Research Coordinator (CRC — Site Level)

  • Level: Entry–Intermediate (BSc/BSN/PharmD)
  • Duration: 8 weeks / 180 hours
  • Curriculum:
    • Site start-up: feasibility, pre-study tasks, EC/IRB
    • Informed consent process & subject screening
    • Visit scheduling, source docs, EDC entry & queries
    • AE/SAE reporting and IP handling at site
    • Site communications, recruitment & retention
  • Format: LMS lessons, site casework, source/EDC practice

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3. Clinical Research Associate (CRA - InHouse)

  • Level: Intermediate (BSc/MSc/PharmD/BSN)
  • Duration: 8 weeks / 180 hours
  • Curriculum:
    • Site selection, SIV, routine monitoring, closeout
    • SDV/SDR, protocol deviations, CAPA follow-through
    • ICH-GCP, ALCOA+, trip report writing, KRI basics
    • IP accountability & reconciliation
    • Vendor & site communication strategies
  • Format: LMS lessons, monitoring sims, report writing labs

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4. Advanced Clinical Research Associate (ACR)

  • Level: Advanced (MSc/PharmD/MD/Experienced CRA)
  • Duration: 8 weeks / 180 hours
  • Curriculum:
    • Complex trials & RBQM (KRIs, risk logs, signals)
    • Issue escalation, audit readiness, inspection support
    • Data trends, deviation taxonomy, CAPA effectiveness
    • Multi-site oversight, mentoring junior staff
    • Metrics, dashboards, quality by design (QbD)
  • Format: LMS lessons, advanced case studies, capstone

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5. Clinical Trial Monitor (CTM — Site Level)

  • Level: Intermediate–Advanced (Experienced CRC/CRA)
  • Duration: 8 weeks / 180 hours
  • Curriculum:
    • Study plan, timelines, risk & resource planning
    • Vendor oversight (CRO, labs, eCOA, eTMF)
    • Budgeting, contracts, change control
    • Quality oversight, metrics & dashboards
    • Inspection readiness & documentation governance
  • Format: LMS lessons, oversight scenarios, templates

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6. Clinical Study Manager (CSM — Leadership)

  • Level: Advanced (MSc/PharmD/MD/Experienced CTM)
  • Duration: 12 weeks / 260 hours
  • Curriculum:
    • End-to-end study leadership & decision making
    • Cross-functional governance (Biostats, PV, Reg, DM)
    • Risk management, issue logs, lessons learned
    • TMF completeness & milestones tracking
    • Budget/forecast, vendor performance management
  • Format: LMS lessons, leadership sims, portfolio project

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7. Clinical Research Operations in AI (CRAI)

  • Level: Intermediate–Advanced (BSc/MSc/PharmD+, Tech-curious)
  • Duration: 8 weeks / 180 hours
  • Curriculum:
    • RBQM with analytics (KRIs/KPIs), signal detection
    • eTMF analytics & completeness scoring
    • AI-assisted feasibility, site targeting & enrollment
    • NLP for deviation/AE narratives & risk notes
    • Compliance & data integrity with AI tools
  • Format: LMS lessons, tool demos, mini-projects

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8. Clinical Trial Role-Based Projects (CRAP)

  • Level: Project-based (All levels; best after CTA/CRC/CRA)
  • Duration: 6 weeks / 150 hours
  • Curriculum:
    • Protocol synopsis → essential docs set-up
    • Monitoring report, ICF package, deviation/CAPA write-ups
    • TMF file plan & QC checklist execution
    • AE/SAE case narrative drafting
    • Closeout checklist & inspection dry-run
  • Format: Guided projects, submissions, mentor feedback

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9. Good Clinical Practice (ICH-GCP — Essentials)

  • Level: Essentials (All levels)
  • Duration: 2 weeks / 40 hours
  • Curriculum:
    • ICH-GCP principles & roles/responsibilities
    • Ethics, consent, safety reporting fundamentals
    • Protocol compliance & documentation standards
    • Data integrity (ALCOA+) & privacy basics
    • GCP assessment & certification prep
  • Format: LMS lessons, quizzes, compliance scenarios

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10. Essential Documents in TMF (TMF — ICH-GCP E6(R2))

  • Level: Essentials–Intermediate (CTA/CRC/CRA/CTM)
  • Duration: 3 weeks / 60 hours
  • Curriculum:
    • TMF Reference Model & taxonomy
    • Filing standards, metadata, versioning
    • Completeness/quality checks & audit trails
    • Study/zone mapping & milestone validations
    • Inspection readiness exercises
  • Format: LMS lessons, filing labs, QC checklists

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11. Informed Consent — Ethics & Compliance (IC)

  • Level: Essentials–Intermediate (CTA/CRC/CRA)
  • Duration: 2 weeks / 40 hours
  • Curriculum:
    • ICF components & process flow (initial & re-consent)
    • Vulnerable populations & safeguards
    • Privacy/HIPAA/region-specific regs overview
    • Documentation, deviations & CAPA handling
    • Role-play scenarios for consent conversations
  • Format: LMS lessons, scenarios, form critique labs

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12. Intro to Clinical Trial Management & Phases (CTM/Phases)

  • Level: Essentials (Entry & cross-functional)
  • Duration: 2 weeks / 40 hours
  • Curriculum:
    • Phases I–IV, designs, endpoints & controls
    • Randomization/blinding & placebo considerations
    • Safety & PV interface; data flow to EDC/SDTM
    • Site activation to closeout overview
    • Stakeholder map & terminology
  • Format: LMS lessons, phase-map exercises, quizzes

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13. Roles in Clinical Trial Management (Roles)

  • Level: Orientation (Entry/Career-change)
  • Duration: 1 week / 20 hours
  • Curriculum:
    • Role charters: CTA, CRC, CRA, CSM, CTM
    • Day-in-the-life, deliverables, success metrics
    • Tools stack (EDC, eTMF, CTMS) & soft skills
    • Career paths & competency frameworks
    • Interview prep & portfolio tips
  • Format: LMS lessons, role cards, mock interview tasks

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14. Site Initiation, Monitoring & Closeout — Basics (SIV/Monitoring)

  • Level: Essentials–Intermediate (CRC/CRA)
  • Duration: 3 weeks / 60 hours
  • Curriculum:
    • SIV agendas, readiness checks & training logs
    • SDV/SDR strategies, query management in EDC
    • Deviation tracking, CAPA, follow-up letters
    • IP accountability & reconciliation basics
    • Closeout requirements & archiving
  • Format: LMS lessons, visit-note labs, checklists

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✅ Why Join Qtech-Sol?

  • ✔️ Role-based learning aligned to CRA, CRC, and CSM job duties
  • ✔️ Protocol-focused simulations and document walkthroughs
  • ✔️ Training aligned with GCP, ICH, FDA, EMA, and Health Canada standards
  • ✔️ Career mentorship and RMS job placement support
  • ✔️ Designed for freshers, working professionals, and career changers

🔜 Next Steps