Clinical Research Mastery
An industry-ready foundation across coordinator, monitoring and study operations work, taught against real protocols.
Program at a glance
- Duration
- 6 weeks, live cohort
- Contact hours
- 220 contact hours, live cohort
- Cadence
- Runs 4 times a year
- Tuition
- $1,997
- Target roles
- Clinical Research Coordinator, Study Assistant, Site Start-Up Associate
Payment plans available. Fees are confirmed in writing before enrolment.
What this program covers.
Who it is for
Beginners, healthcare professionals new to clinical research, and career switchers.
Entry expectations
- No prior clinical research experience required
- A healthcare, life science or research-adjacent background helps but is not essential
- Comfortable attending live sessions and completing practical work between them
What you leave with
- Foundation across CRC, CRA and study operations
- Internationally recognised competencies employers look for
- Live instruction using real-world protocols
Week by week.
Every module pairs live instruction with practical work that is reviewed against defined criteria.
Week 1, foundations
Drug development, global regulation and career pathways
- Sponsors, CROs, sites and who owns which decision
- ICH GCP E6(R3) applied to daily site tasks, not recited
- Protocol anatomy: reading a study the way a coordinator does
- Capstone.
- Strategic trial context
- Role lens.
- All entry-level roles introduced
Week 2, start-up part 1
Pre-activation regulatory work and site qualification
- Feasibility, site selection and start-up timelines
- Regulatory binder and TMF expectations
- Ethics submissions and approval workflow
- Capstone.
- Pre-activation regulatory and site qualification
- Role lens.
- Regulatory operations
Week 3, start-up part 2
Site activation and operational readiness
- Activation checklists, training records and delegation logs
- Vendor, lab and supply readiness before first participant
- Running a site initiation visit as the site contact
- Capstone.
- Site activation and operational readiness
- Role lens.
- Clinical trials assistant
Week 4, conduct part 1
Participant-facing conduct and data operations
- Running a consent discussion and documenting it defensibly
- Visit windows, procedures and scheduling
- ALCOA+ source records, EDC entry and query resolution
- Capstone.
- Participant-facing conduct and data operations
- Role lens.
- Clinical data coordinator
Week 5, conduct part 2
Safety oversight and monitoring execution
- AE, SAE and SUSAR handling with reporting timelines
- IP accountability, storage and dispensing records
- Working with the monitor through an interim monitoring visit
- Capstone.
- Safety oversight and monitoring execution
- Role lens.
- Drug safety, pharmacovigilance and CRA
Week 6, closeout and quality
Trial closure, quality defence and interview readiness
- Closeout activities, reconciliation and archiving
- Assemble your work into a Competency Labs by TRUVAN casebook
- Interview practice against role-specific scenarios
- Capstone.
- Trial closure and quality defence
- Role lens.
- Quality assurance, all roles converge
What enrolment includes.
- Live instruction from an IAOCR Accredited Trainer
- Six rolling capstones marked against defined criteria
- Hands-on EDC practice on a teaching study
- Recordings and program materials retained after the cohort
- Entry into a Competency Labs by TRUVAN casebook to build reviewed evidence
- TRUVAN Academy certificate of completion
Rudy Malle personally holds a current Q-IAOCR accreditation as an Internationally Qualified Clinical Research Trainer, Trainer No. 16167194. Every TRUVAN Academy program is designed and delivered by Rudy, so learners are trained by an IAOCR Accredited Trainer. A TRUVAN Academy certificate of completion is issued by TRUVAN only and is not an IAOCR credential. Reviewed evidence still comes from demonstrated work in Competency Labs by TRUVAN.
Roles this prepares you for.
Every capstone has a core requirement plus an optional deeper section, so you can weight your work towards the role you are targeting.
- Clinical Research CoordinatorView cohort dates and fee
- Clinical Trials AssistantView cohort dates and fee
- In-House CRAView Site to CRA
- Drug Safety SpecialistView cohort dates and fee
- Pharmacovigilance SpecialistView cohort dates and fee
- Clinical Data CoordinatorView cohort dates and fee
- Regulatory Affairs AssociateView cohort dates and fee
- Site Activation SpecialistView cohort dates and fee
- Quality Assurance AssociateView cohort dates and fee
- Clinical Project CoordinatorView cohort dates and fee
Is this you?
A good fit if you
- Want to enter clinical research and have no site experience yet
- Are a nurse, pharmacist, scientist or laboratory professional changing direction
- Have been applying without callbacks and need demonstrated work to show
- Want hands-on practice rather than lecture slides
- Can hold a consistent weekly commitment for six weeks
Backgrounds people arrive from
- Registered nurses and other bedside clinicians
- Pharmacists and PharmD graduates
- Life science graduates in biology, chemistry or public health
- Medical laboratory technologists
- Healthcare and science-adjacent career changers
What you get access to.
Practice environments and job-search tooling that come with enrolment, so the work you do turns into something you can show.
Hands-on EDC practice
Work in an electronic data capture environment built to mirror sponsor study setups, so data entry is something you have done rather than read about.
- eCRF entry, queries and source data verification
- A set of completed forms you can talk through in interview
Competency Labs by TRUVAN access
Role-specific casebooks and simulations. Completed work is scored against defined criteria and becomes your evidence record.
- Scenarios across coordinator, monitoring and data paths
- Replay protocol, safety and monitoring workflows as often as needed
Job-search tooling
Résumé and application tooling used alongside the program so your search starts the week you finish.
- Résumé and cover letter versions tuned per application
- Application tracking and interview preparation
Upcoming cohorts.
Dates, application deadlines and format for each cohort. Applying is not an offer of a place; we confirm your cohort by email.
Next cohort being scheduled.
Dates for this program are not published yet. Apply below and we will send the schedule as soon as it is confirmed.
How enrolment works.
This program is application based. No payment is taken on the site.
Step 1
Apply
Answer a short set of qualifying questions. It takes about two minutes and no payment is taken on the site.
Step 2
Review
We review your application and respond by email, normally within two working days.
Step 3
Enrol
Confirm your cohort on an admissions call. Fees and payment plan are set out in writing before you commit.
About ten minutes. No payment on the site.
Before you apply.
Still have questions?
Talk to admissions about fit, cohort timing or funding before you apply. We reply within one business day.
Apply to Clinical Research Mastery.
The full application takes about ten minutes and covers your background, target role, availability and funding. We read every answer and reply within one business day.
We reply within one business day.
Ask about Clinical Research Mastery.
Short form. We reply within one business day with cohort dates, format and next steps. Submitting an application is not an offer of a place.