Internationally Qualified Clinical Research Site Manager Accreditation
Internationally Qualified Clinical Research Site Manager Accreditation
Internationally accepted professional accreditation standard for Clinical Research Site Managers. Suitable for professionals already working as a Clinical Research Site Manager as well as those looking to transition into the role (who already have the required experience or have completed training for this role and want to evidence their competence to Sponsors. CROs, employers and patients.)
60 CPE Points / 6 Learning Credits
Registration deadline: 26 Sep / 24 Oct / 28 Nov
Select your chosen cohort start date to commence registration.
Important – by registering you are confirming (a) you have read and agree to the Terms and Conditions and (b) you are self-certifying that you meet the entry criteria for this accreditation (as detailed below on this page).
ICH-GCP is not required to complete this accreditation, however by including the ICH-GCP, learners will receive an additional 20 CPE points.
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Entry Requirements
Before enrolling on the Q-IAOCR Internationally Qualified Clinical Research Site Manager program, it is important that you confirm that your career and educational background has provided you with the necessary experience to complete the competence assessment areas listed below.
Please ensure that you have self-certified your ability to complete the accreditation assessment before enrolling on the programme by confirming your experience in the following assessment areas (which are applicable to the level of responsibility for a Clinical Research Site Manager):
- Regulatory frameworks and reporting requirements for clinical trials
- Clinical trial protocols and designs
- Data management and data integrity in clinical trials
- Patient rights, safety, consent, confidentiality in clinical trials
- Data collection in clinical trials (including DCTs)
- Drug development process
- Management & communication in clinical trials
- Document maintenance & budget management
- Process and relevant documentation for start-up and close-out
- Quality and risk management in clinical trials
- Understanding of the Investigational Medicinal Product (IMP)
- Role of stakeholders in clinical trials
- ICH-GCP and good clinical practice
Accreditation Outline
The Internationally Qualified Clinical Research Site Manager (QM-IAOCR) professional standard was developed in conjunction with global clinical trial experts and enables successful participants to achieve accreditation and professional recognition as a Clinical Research Site Manager. You may already have a Clinical Research Site Manager Certification, and are now looking to achieve a formal, internationally accepted accreditation to demonstrate your ability to work to best-practice global standards.
Individuals must provide evidence that they can demonstrate all the relevant core competencies expected of a competent Clinical Research Site Manager*. The accreditation process is focused on determining whether someone has the skills, knowledge and behaviours to fulfil their role, measured against a set of robust accredited assessment criteria which have been developed from the core competency framework validated by the industry.
This unique and independently accredited program uses assessment criteria mapped to the International Standard Classification of Education developed by UNESCO. Participants successfully passing the accreditation assessment are awarded IAOCR Internationally Qualified Status (QM-IAOCR), which is internationally accepted and familiar to educational establishments and employers globally.
- Please note that IAOCR does not provide training. The purpose of our accreditations is to competence verify individuals who have already received training through another provider, and/or gained the necessary ‘on the job’ experience. (See entry requirements for further details).
- All our career accreditation programs are developed from global core competency frameworks ratified by the industry for that specific role. However, they do not assess competency in local/country laws or regulations that may be applicable to your role in your region/country. Please ensure that you take responsibility to be competent in any relevant local/country legislation in addition to receiving IAOCR international accreditation
Registration Dates
The cohort registration dates for Q-IAOCR Internationally Qualified Clinical Research Site Manager are below:
Award of Accreditation Certificates and Professional Certification Marks normally happens within 9 weeks of assessment submission.
If your preferred start date is not currently listed, you can register your interest and we will contact you when registration opens. Please contact us clearly stating which program you are interested in.
NOTE: Please ensure you have read the Terms and Conditions of Sale for IAOCR Accreditation Programs, as this contains important information about program completion, cancellations and deferrals. You will be asked to confirm that you have read these before completing the purchase check out process.
What does the Accreditation assessment involve?
Normally one working day before the program start date, you will be sent a link to access your online assessment portal. The assessment is a blend of multiple-choice questions, questions requiring free text answers and interactive scenarios designed to test your competence as a site-based Clinical Research Co-ordinator (this is your ‘Portfolio of Evidence’). Upon completion of your assessment, your portfolio will be sent to the IAOCR Assessment team for review and independent verification.
If you have successfully passed the accreditation you will be awarded the following:
- A Certificate of Accreditation
- A Professional Certification Mark (displaying your award date, unique registration number and the title of your accreditation)
- The Designatory letters QM-IAOCR – Internationally Qualified Clinical Research Site Manager
How long does the assesment take to complete?
On average, the assessment takes up to 2 hours to complete. You can complete the assessment in your own time, but you must ensure that your final submission adheres to the deadline for assessment submission according to your registration date.