Site to CRA
The bridge from site execution to monitoring: current ICH GCP E6(R3), source verification in a real EDC, visits run end to end and a co-monitoring shadow visit with a working CRA.
Program at a glance
- Duration
- 6 weeks, live cohort
- Contact hours
- 12 live sessions, 24 hours of live instruction, 60 lessons
- Cadence
- Runs 2 times a year
- Tuition
- $2,497
- Target roles
- Clinical Research Associate, In-House CRA, Centralised or Remote CRA
Payment plans available. Fees are confirmed in writing before enrolment.
What this program covers.
Who it is for
Coordinators, study and regulatory coordinators, research nurses, lab and pharmacy site staff crossing over into sponsor and CRO monitoring.
Entry expectations
- Current or recent site experience such as coordinator, research nurse, regulatory coordinator or site staff
- Working familiarity with protocols, source documents and study visits
- Around 8 to 10 hours a week across the six weeks, including self-paced work
What you leave with
- Run site initiation, interim and close-out visits to inspection-ready standards
- SDV and SDR in a real EDC, plus orientation across the systems sponsors use
- A monitoring portfolio and reviewed evidence hiring teams can review
Week by week.
Every module pairs live instruction with practical work that is reviewed against defined criteria.
Week 1
ICH GCP E6(R3) foundations and the modern trial ecosystem
- Current E6(R3) rather than the legacy R2 curriculum
- Who owns which decision across sponsor, CRO and site
- Where a monitor's judgement actually changes the outcome
- Capstone.
- Read the cohort protocol and map the CRA decision points
- Role lens.
- Sponsor and CRO oversight
Week 2
Site qualification and trial initiation
- Feasibility, qualification and selection from the sponsor side
- Initiation agendas, training records and delegation review
- Readiness checks before the first participant is consented
- Capstone.
- Run a mock site initiation visit end to end
- Role lens.
- Start-up monitoring
Week 3
Monitoring, SDV and SDR, RBQM and decentralised trials
- Source verification and source review against critical data
- Risk-based quality management and centralised signals
- Decentralised and hybrid visit models
- Capstone.
- Mock SDV and SDR in a real EDC with case data
- Role lens.
- Interim monitoring
Week 4
Documentation, TMF and the co-monitoring shadow visit
- Investigator site file and TMF completeness from the monitor's side
- Protocol deviations, root cause and corrective action
- Shadow a co-monitoring visit with a working CRO CRA
- Capstone.
- Audit a mock investigator site file and write a sponsor-ready CAPA
- Role lens.
- Quality and documentation
Week 5
Safety, IP accountability, close-out and the sponsor relationship
- AE, SAE and SUSAR assessment against reporting timelines
- Investigational product accountability and reconciliation
- Holding the sponsor, CRO and site triangle without losing trust
- Capstone.
- Complex AE and SAE assessment plus a mock IP reconciliation
- Role lens.
- Safety and supply oversight
Week 6
Land well, perform excellently, get promoted
- Assemble visit reports and follow-up letters into a casebook
- CRA interview simulations and report critique
- Introduction into TRUVAN Careers job-search support
- Capstone.
- Submit the final Competency Labs by TRUVAN casebook portfolio
- Role lens.
- Placement and evidence
What enrolment includes.
- Live instruction from an IAOCR Accredited Trainer
- One real published Phase II or III protocol threaded through every module
- Co-monitoring shadow visit with a working CRO CRA
- Monitoring visit report and follow-up letter reviewed against criteria
- CRA casebook entry in Competency Labs by TRUVAN for reviewed evidence
- Recordings and materials retained after the cohort
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 Associate IView cohort dates and fee
- In-House CRAView cohort dates and fee
- Site-Support CRAView cohort dates and fee
- Centralised CRAView cohort dates and fee
- Remote CRAView cohort dates and fee
- CRA bridge and academy programs at large CROsView cohort dates and fee
Is this you?
A good fit if you
- Work at a site as a coordinator, regulatory coordinator, research nurse, lab or pharmacy staff
- Have been applying to CRA roles and hearing that you lack monitoring experience
- Want current regulation, E6(R3) rather than R2
- Want practical work an employer can review rather than a slide deck
- Can hold 8 to 10 hours a week for six weeks alongside a full-time role
Not the right starting point if you
- Have no clinical research site experience yet, start with Clinical Research Mastery
- Want a self-paced course with no live sessions
- Are looking for a guaranteed placement rather than demonstrated capability
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 access
Practice source verification, query resolution and site workflows inside a real electronic data capture environment, the same category of tool sponsors and CROs use.
- Multi-week hands-on access with guided walkthroughs
- Orientation across the other EDC systems you will meet in interview
Competency Labs by TRUVAN access
Monitoring casebooks and simulations where completed work is scored against defined criteria and becomes your evidence record.
- Scenario-based monitoring challenges
- Evidence added to your evidence record
Job-search tooling
Résumé, LinkedIn and interview tooling used alongside the program so your CRA search starts the week you finish.
- Résumé and LinkedIn versions tuned per application
- Interview preparation and application tracking
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 Site to CRA.
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 Site to CRA.
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.