About Us

CRA School – Montreal is the only provider of bilingual International Clinical Research Education, combined with 2 internships and unlimited Job Placement Support that continues till hired.

Special programs are offered to GCP-trained professionals, MDs/PharmDs and MSc/PhD holders in career change, corporate staff and IRB/IEC/REB members.

Our Mission

The program’s objective is to provide all the necessary tools and  know-how that allow faster access into the rewarding careers in Clinical Research and Regulatory Affairs (CRA, CRC, CTA, SSU, RA, DM, PM, PV, MSL, etc.) that match their qualifications.

Customized corporate training and refresher courses on ICH GCP and the Canadian regulations. Quebec regulations are provided on request.

The clinical trials industry:

Recent technological developments and scientific discoveries have substantially increased the possibilities of creating new therapeutic molecules and devices. Before being approved for marketing they must be tested on humans. However, the number of clinical trials grows faster than the introduction of new trained specialists, because they usually lack practical experience. As a result, there is a chronic shortage of qualified staff (30% or more according to different reports).

This shortage increases the demand and raises the salary level. Once a person enters into the field and gets 6-9 months ‘hands-on’ experience, the recruiters start calling to offer better paid jobs. CRAs say, ‘Once you are in, you are in‘. This placed the Senior CRA job among the 10 best jobs in USA and this level can be reached with only 5-6 years experience.

Clinical trials:

Clinical trials are experimental studies to statistically assess the safety and efficiency of newly-developed drug candidates or devices and their action on the human health, the ratio of the related benefits and risks, and the suitable treatment regimens. After the pre-clinical laboratory studies on animals have shown product safety, the studies continue on humans in medical clinics (hence the name “clinical trials“) under the supervision of qualified physicians, called Clinical Investigators.

Patient evaluations are carried out by their respective physicians, called Principal Investigators (PI), with the help of their Study Nurses (SN) and Clinical Research Coordinators (CRC). The control of their work is done by the Sponsor’s Monitors called Clinical Research Associates (CRA).

Roles in clinical trials:

The regulatory agencies (FDA, Health Canada or other) inspect only a small portion (about 2%) of all studies. The law requires that the Sponsor (the company or individual investigator that initiated the study) to continuously monitor the quality of the data generated and to ensure that the rights and safety of the study participants are protected. The physicians (PI or Sub-I) are responsible for the evaluation of their patients and the quality of the data generated in their sites.

The data management, quality control and statistical treatment of the study data is done by the Sponsor’s staff, the Clinical Trial Assistants (CTA), in-house or field Monitors or Clinical Research Associates (CRA), Data Managers (DM), Safety Managers, Medical Advisers, BioStatisticians, Project Managers and other staff trained on Study Protocol, clinical trial regulations and the sponsor’s Standard Operations Procedures (SOP).

What is a CRA and a CRC:

The field Clinical Research Associate (CRA) is an monitor who periodically visits the study sites to supervise and inspect the work of the Clinical Investigators and their Coordinators. The CRA verifies their compliance to the protocol and regulations, makes sure that all regulatory requirements are met and that the quality of the data is acceptable. The in-house CRA and the CTA organize all Sponsor’s study related activities.

The Clinical Research Coordinators (CRC) are Clinical research assistants who work in the medical clinics (called sites) where the studies take place. They organize all interactions with the study participants and all study-related activities at the site. (The Principal Investigator (PI) is responsible for the patients’ care, evaluations, and the conformity of all the study conduct with the law and clinical trial regulations in force.)

Target audience:

Companies look for functional English and a university diploma. Life sciences, health care, biology, biochemistry, biomedical engineering, social sciences, or other medical field are preferred. This guarantees that the candidate will be able to understand a research protocol when trained.

The eligibility criteria usually include a college or university diploma. For some high level jobs, an advanced scientific degree is required. The best hiring chances are for professionals who have already some practical experience in clinical research activities. This is always the 1st hiring criterion.

International candidates:

Health professionals, trained abroad, often have difficulties when they move to another country. Foreign diplomas often are not recognized and the required local experience is missing. 

Regulatory affairs jobs allow these professionals to remain in their field of competency without needing a recognized diploma.

With the exception of the clinical investigators and their nurses, the other Clinical Research Professionals (CRAs/CRCs/CTAs, etc.) don’t perform medical acts, they only handle study organization and documentation without making interpretations of the study data. Therefore they don’t need to have a license to practice as medical professionals.