Do I need to be a coordinator to apply?

Most participants come from site-side roles such as coordinator, regulatory coordinator, research nurse, lab or pharmacy staff. If you have worked at a research site, you are in scope.

How current is the regulatory content?

The program teaches ICH GCP E6(R3), including risk-based quality management, quality by design, critical-to-quality factors, decentralised trials and data governance. It does not teach the legacy E6(R2).

Will I get hands-on with a real EDC?

Yes. You practice source verification and query resolution in a live EDC environment, with orientation across the other systems sponsors and CROs commonly run.

Can I do this while working full-time?

Yes. Live sessions run in the evening and the total commitment is around 8 to 10 hours a week including self-paced work.

Is the program accredited?

No. Your trainer holds an individual IAOCR accreditation. The program itself is not IAOCR accredited and the certificate of completion is issued by BORAKA only.

Will this get me a CRA role?

No program can guarantee a role. This one builds the monitoring skill set and the demonstrated evidence hiring teams ask for, then introduces the separately scoped Career Services services if you want search help.

BORAKA Academy program

Site-to-CRA Bridge

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.

Take the two-minute diagnostic All programs

Applications open

Site-to-CRA Bridge: Fall 2026

Dates.: 12-OCT-2026 to 21-NOV-2026
Seats.: 24 remaining of 24
Cadence.: 3 to 4 cohorts a year

Apply now See all cohort dates

Duration: 6 weeks, live cohort
Contact hours: 12 live sessions, 24 hours of live instruction, 60 lessons
Cadence: 3 to 4 cohorts a year
Tuition: $2,997
Target roles: Clinical Research Associate, In-House CRA, Centralised or Remote CRA

Pay in full, or 3 payments of $1,149 for a $3,447 total. The payment plan costs more than paying in full because BORAKA carries the additional payment and collection risk. Fees are confirmed in writing before enrollment.

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 reviewed evidence hiring teams can review

Before week one

What happens after you are accepted.

Week 0 sets up your schedule, access and expectations, so the first live session starts on content rather than admin.

Week 0, day 1
Acceptance and cohort confirmation
You receive a written confirmation of your cohort, the live session pattern in your timezone and the weekly time commitment to plan for.
Week 0, day 2
Access to the learning workspace
Your Academy workspace opens with the schedule, the module outline and the criteria each piece of practical work is reviewed against.
Week 0, day 3
Pre-work and systems check
Short pre-work sets a shared baseline, and you test access to the practice environments used during the cohort before week one starts.
Week 0, day 5
Orientation session
A live orientation covers how the weekly capstones work, how feedback is given and what you are expected to produce by the final week.

What you produce by the final week

A monitoring visit report, a follow-up letter, a CAPA and a completed casebook portfolio, each reviewed against defined criteria. Reviewed work becomes evidence you can show. A certificate of completion records attendance and completed work; it is not a competency credential on its own.

Curriculum

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 judgment actually changes the outcome

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

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

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

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

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 Career Services job-search support

Included

What enrollment 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 BORAKA Academy casebooks for reviewed evidence
Recordings and materials retained after the cohort
Baseline CRA-readiness assessment before training
Final post-training competency assessment across the same competency domains
One included human expert verification review
Verified competency record updated where the threshold is met
Competency Labs access during the program
BORAKA Academy certificate of completion

Rudy Malle personally holds a current Q-IAOCR accreditation as an Internationally Qualified Clinical Research Trainer, Trainer No. 16167194. Every BORAKA Academy program is designed and delivered by Rudy, so learners are trained by an IAOCR Accredited Trainer. A BORAKA Academy certificate of completion is issued by BORAKA only and is not an IAOCR credential. Reviewed evidence still comes from demonstrated work in BORAKA Academy casebooks.

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.

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

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 Career 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 enrollment, 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

Practice casebooks 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 you can run your own CRA search when the six weeks end.

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.

Runs three to four times a year. Frequent intakes, kept small enough for every monitoring practice group to be reviewed.

Applications open

Fall 2026

Dates.: 12-OCT-2026 to 21-NOV-2026
Format.: Live online, America/New_York
Seats.: 24 remaining of 24

Apply for this cohort

Can’t make this cohort?

Get the next cohort dates before applications open. This is not a waitlist and it does not hold a seat.

Enrollment

How enrollment works.

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

Step 1
Apply
Complete the full application covering your background, target role, availability and funding. It takes about ten minutes and no payment is taken on the site.
Step 2
Review
We read every answer and reply by email within one business day.
Step 3
Enroll
If your application is accepted, you confirm your cohort on an enrollment conversation. Fees and payment plan are set out in writing before you commit, and optional Career Services services can be discussed there without any obligation to add one.

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 admissions Start application

Apply

Apply to Site-to-CRA Bridge.

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 application Just send me the dates

We reply within one business day.

Apply to a program

Ask about Site-to-CRA Bridge.

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.