Course Outline

Module I

1 The pharmaceutical industry, Glossary
2 History of the clinical trials regulations
3 Ethics in research, Medical terminology
4 Phases of clinical trials
5 Role & tasks of Sponsor, PI, CRC & CRA

Module II

6 Overview of drug regulatory process, 21 CFR
7 ICH GCP, Canada Clinical Trials Regulations
8 Institutional Review Board, IRB/IEC/REB
9 Informed Consent Process, ICD design
10 Safety monitoring and AE/SAE reporting

Module III

11 Study Preparation and Design
12 Fundamentals of clinical trials conduct
13 Design of Clinical Trial Protocols
14 Design of Case Report Forms (CRF)
15 Site management, Recruitment, Retention

Module IV (not included in the CRC/PI course)

16 Site Evaluation and Site Selection Visit
17 Investigator Meeting & Site Initiation Visit
18 Site Monitoring Visit, Risk Based Monitoring
19 Study Termination, Site Close-Out Visit
20 Preventing Errors, Fraud and Misconduct

Module V

21 Clinical Trial Data Management
22 HIPAA Compliance Requirements
23 Data Safety Monitoring Board
24 Clinical Trial Management Systems
25 Audits and Inspections

Module VI

26 Essential documents in clinical trials
27 Medical devices regulations in US & Canada
28 Pre-market notification, FDA 510(k), PMN
29 Investigational Device Exemption, IDE
30 Medical Devices Pre-market Approval, PMA

Module VII (Job insertion Support, provided in parallel to the regulatory training)

31 Monitoring Efficiency, Time management for CR Professionals (for CCRP-01 only)
32 CV adaptation for clinical research jobs and professional branding (ongoing)
33 Networking 2.0 – coaching on the use of professional social media (ongoing)
34 Job descriptions analysis and Interview preparation (after Module II, till hire)
35 Unlimited Internship in E-CRO environment (from chapter 1, ongoing till hire)

Course Registration

CCRP (CRA+CRC) Certification ProgramCCRP-01 This program covers pratically all the activities of the different players in the clinical trials: the coordinator who does all the work at the clinical site, and the monitor of the sponsor who verifies if the work is done in compliance with the protocol and the regulations as an inspector he must be familiar with everything done in the frame of a clinical study.

*The tuition fees depend on several factors: preferred number of installments, way of payment and eligibility to the Accessibility Program for Canadian cadidates without revenue, monoparental families and newcomers (less than 5 years in Canada).

Alternative courses

CCRC (PI+CRC) Certification ProgramCCRP-02 This program covers the activities done at the clinical site by the Clinical investigators (PI and sub-Is) and the clinical research coordinators (CRC) called sometimes research nurses (RN) or study coordinators (SC). It doesn't cover the work done by the sponsor in the pharmaceutical companies or CROs (contract research organizations).

For consultantsCCRP-03 This program is designed for GCP qualified professionnals who are willing to acquire some Canadian experience by contributing as pro-bono CRA training assistant and in improving the training content while studying the Canadian and Quebec (optional) regulations. A 55% discount is granted in exchange for their support.

Additional courses

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** Indicated prices apply for beneficiaries of the Accessibility program only. Contact Customer service for details.

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If you have questions about the additional courses, please contact Customer service.

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Refer a friend
  • Hidden jobs

    Working in the administration, management and monitoring of clinical trials is an interesting, but virtually unknown career opportunity. In 90-95% of the cases the positions in this field are filled-in internally or by referrals and not published at all.

    For this reason the clinical research professions (code of Canadian professions 4165) are often out of the radars of qualified professionals facing a career change. The employment counselors also don’t know much about them and the chronic shortage of trained staff in this field. It makes sense to inform your friends who have B.A., Life science, or Health/Allied Health diplomas about this non popular, but rewarding career option.

    We consider that if you inform a friend about these career opportunity and our unique job insertion program, such targeted distribution of information is much better that unfocused and expensive publicity in newspapers or Internet.

  • Unique approach

    As professionals in career change need a job, and not another diploma, this unique program addresses all these obstacles by providing the necessary tools for overcoming them:
    – regulatory training, combined with practical advices how to perform each task in the real life,
    – unlimited internship in e-CRO environment to get the required Canadian experience,
    – networking assistance to access the hidden job market that continues till hired, and
    – job insertion coaching & mentoring with interview preparation & analysis till hire.

  • Difficult access to these jobs

    The Job Insertion Program till hire, provided in parallel to the regulatory course, is unique. University courses in clinical research don’t cover monitoring in details and don’t offer such internships to provide “hands-on experience”. They usually give only training on the regulations, which are public and easily accessible. They don’t address the main obstacles that people in career change face:
    – how to get access to these 90-95% of hidden jobs when you know nobody and nobody knows you in this new field, and often, in a new country?
    – how to get all the industry specific practical know-how, not described in the regulations, in order to pass successfully an interview without losing years to postulate in vain?
    – how to beat the famous Catch 22 vicious circle ‘No experience – no job – no experience’, and satisfy the main hiring criteria – ‘hands-on’ experience in the required clinical trial related tasks.

  • Unlimited number of bonuses

    If you register in our database the name of the person who you informed about this opportunity, you will get a 10% bonus when the person subscribes to the program and finishes all payments. The database will generate automatically a Credit note even if this happens years later. Bonuses can be used also to cover your next payment, if you wish so. The number of bonuses is unlimited.