YANA Careers is becoming Wonja Academy. Competency Labs is becoming Wonja Labs.

Read the transition note
WONJA
Wonja Academy program

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 online 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.

See cohort dates and fee
Program detail

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 Passport evidence hiring teams can review
Curriculum

Week by week.

Every module pairs live instruction with practical work that is reviewed against defined criteria.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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 Wonja Talent job-search support
Included

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 Wonja Labs for Passport 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 Wonja Academy program is designed and delivered by Rudy, so learners are trained by an IAOCR Accredited Trainer. A Wonja Academy certificate of completion is issued by Wonja only and is not an IAOCR credential. Passport evidence still comes from demonstrated work in Wonja Labs.

Role pathways

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.

The right fit

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
Included tooling

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

Wonja Labs access

Monitoring casebooks and simulations where completed work is scored against defined criteria and becomes the evidence behind your Passport.

  • Scenario-based monitoring challenges
  • Evidence attached to your Passport 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
Schedule

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.

Enrolment

How enrolment works.

This program is application based. No payment is taken on the site.

  1. Apply

    Answer a short set of qualifying questions. It takes about two minutes and no payment is taken on the site.

  2. Review

    We review your application and respond by email, normally within two working days.

  3. Enrol

    Confirm your cohort on an admissions call. Fees and payment plan are set out in writing before you commit.

Start the application

About ten minutes. No payment on the site.

Questions

Before you apply.

Still have questions?

Talk to admissions about fit, cohort timing or funding before you apply. We reply within one business day.

Talk to admissionsStart application
Apply

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.

Start the applicationJust send me the dates

We reply within one business day.

Apply to a program

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.