Graduates of this program can be employed both in the hospital sector and research industry. Clinical research professionals work in a broad range of research settings:
CRA positions: in-house or field CRAs, including home-based 1 work mainly in:
- Contract Research Organizations (CRO)
- Pharmaceutical Companies
- Biotechnology Companies
- Biologics Manufacturers 
- Cosmetics Manufacturers
- Medical Device Manufacturers
- Diagnostic Products Manufacturers
CRC positions (in-house positions) are available mainly in:
- Academic Research Centers
- University Teaching Hospitals
- Hospital Clinical Research Units
- Part-Time Research Units
- Private Medical Clinics
- Private Research sites
- Site Management Organizations (SMO)
 If the company has a local branch, the CRAs must go to the office when not on the road and perform other administrative tasks if needed. Experienced field CRAs can also work as home-based if the company is small or medium sized and doesn’t have a branch in the city. The employer provides everything necessary to organize a home office and the home-based CRAs work from their homes without a secretary. They travel to monitor the investigative sites and email their reports when back home. All of their costs are reimbursed by the company.
 Biologics are medicinal products created by biological processes (not chemically), such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy products, tissues, recombinant proteins etc.
Why Become a CRA?
Recent technological developments and scientific discoveries have substantially increased the possibility of creating new therapeutic molecules and devices, whic need to be tested on humans and approved before marketing. The number of clinical trials grows faster than the introduction of newly-trained professionals. The result is a chronic shortage of qualified staff in the field of the clinical trials, which increases the demand and raises salary levels. In the last US Jobs Survey, the SrCRA job has been placed among the 10 best jobs in the USA.
The specific set of skills and knowledge required for this field is not sufficiently covered by current regular university courses. Some colleges and universities offer continuing education programs for Clinical Research Professionals, but in general, the education system does not seem to produce enough experienced graduates to meet the demand for entry-level positions like Clinical Research Associates (CRA-I), Clinical Research Coordinators (CRC), Data Managers (DM), Quality Assurance (QA) and Regulatory Affairs (RA) Specialists, etc. For this reason, once a person starts working, after 6-9 months the recruiters start calling to offer better positions in another company. Once you are in, you are in forever.
The Clinical Research Professional (CRP) Certification program prepares Certified Clinical Research Professionals for many of the principal jobs involved in clinical trials.
As a monitor/auditor (called Inspector when working for the governmental regulatory agency), the CRA must know all aspects of a clinical trial. As assistant to the Clinical Investigator, the CRC organizes everything done in the clinic (research site), except the medical acts, performed by the licensed physicians, nurses and medical technologists.
Our certification course provides the foundation for all jobs of interest both in pharmaceutical companies, CROs, and in hospitals or university clinical research centers.
The Clinical Research Associate (CRA)
A Clinical Research Associate (CRA) is a representative of the company sponsoring the clinical trials. They visit trial sites to monitor progress and ensure that the sponsor’s SOPs are being followed, and that Good Clinical Practice (GCP) or other regulations are respected. The CRA helps facilitate the trial by training the personnel on the SOPs and by ensuring that the sponsor’s goals are understood. The CRA reports problems back to the sponsor and brings solutions back to the site. They play a critical role as information interface between the sponsor and site.
CRAs require excellent organizational skills, as they are expected to travel frequently between sites hosting different trials (often, 80% of the traditional CRA’s work time is on the road – with technological advances, home-based CRAs are gaining in popularity). They need to verify a huge amount of paperwork and be on the constant lookout for errors or even catch fraudulent activity. CRAs need good “people (soft) skills” to work efficiently.
The Clinical Research Coordinator (CRC)
The Clinical Research Coordinator (CRC) is a clinical research professional who has a central role in ensuring that trials proceed smoothly. The CRC handles many of the day-to-day non-medical activities concerning the trial. Under the direction of the Principal Investigator (PI), the CRC makes sure that many critical details are taken care of.
As the title suggest, the CRC coordinates the site activities, including duties that may include administrative, inventory, communication, HR and giving any other assistance required to keep the clinical trial on track. The CRC may arrange meetings, schedule appointments, order supplies, educate trial subjects, train personnel, create and organize documents, assess eligibility criteria and conduct some procedures, if authorized by the PI. In short, many people rely on the expertise of the CRC, who is often described as the “heart and soul” of the trial.
The CRC works directly with many of the other players in the clinical trial, including the trial subjects, the sponsor, trial personnel, regulatory agencies, other trial sites, suppliers and many others. As with many other positions within clinical research, organizational and communication abilities are very important.
The Data Manager
The Data Manager is in charge of designing and implementing systems to produce data. Without clean, usable data, clinical trials are useless, and so this job is critical to the goals of the sponsor. The Data Manager and their team create a data management plan and protocols for effective data gathering.
As trial data is created, the DM team must review it, organize it in the database and ensure that the flow of data accurately reflects the designs of the trial. This team does not analyze the data to draw conclusions – this job is done by the biostatistician.
A clinical trial is only as good as the data it produces and the ability of someone to analyze the data to draw logical conclusions. The biostatistician has critical roles in both designing the trial to respond to statistical goals, and in interpreting the resulting data.
Without rigorous statistical control, regulatory authorities will not approve the investigational product and huge amounts of money may be lost, and so the biostatistician is critically important in the clinical trial process. Statistical design and analysis is highly regulated, as this is an area that can easily be abused, to “improve” results and cut corners.
The Clinical Quality Assurance Auditor
Clinical Quality Assurance (CQA) Auditors apply QA processes to the clinical trial to ensure compliance with GCP and SOPs. As regulations become increasingly complex and global, the role of CQA is becoming more important. The CRA must identify and report QA problems before they lead to serious issues with the regulatory authorities. Conducting audits requires employees with strong organizational and interviewing skills.
Governmental bodies develop strict regulations to protect the public from dangerous or ineffective products. Regulatory Affairs (RA) specialists within the health product sector work with governments and industry to guide the process of pharmaceutical or medical device development and marketing. RA specialists ensure that clinical trials meet compliance standards.
Most RA specialists in the pharma/medical device industry have higher degrees, but there is little formal training for direct entry into this field. RA positions are generally very demanding and attract people with experience in various competencies including project management. The RA specialist will review lengthy regulatory documents under time-constraints and other pressures, however, the job is financially and professionally rewarding and can lead to many other related positions within industry or the government.
Clinical Safety Specialist
Adverse Events (AEs) are unintended medical problems that occur during a clinical trial. Since these AEs may be related to the investigational product, it is extremely important that they be carefully considered and assessed.
The Clinical Safety Specialist is in charge or monitoring and communicating AEs to the regulatory body (FDA) during clinical trials. They are responsible for ensuring that patients/trial subjects receive appropriate medical attention. This position is often filled by nurses with experience in the field of clinical trials.
Pharmacovigilance specialist (PV)
The PV and Drug Safety specialist is concerned with the monitoring, research and assessment of products in order to seek any new and adverse side effects that may have arisen since the clinical development stage.
Their role is focused on safety reporting for marketed products and risk management. They also make sure that all new information is made available to patients to inform them of the safe and effective use of the product.
They focus in the areas of:
- Drug Safety Risk Management
- Writing Risk Management Plan for Marketing Authorization Application Dossier
- Provision of QPPV Services
- Signal detection, analysis and evaluation
- Product Risk Management (RiskMAPs; REMS and RMPs); PIPs
- PV systems Validation
- PV Inspections / Audit (FDA, EMA, MHRA others)
- Medical review
- Serious Adverse Event (SAE) processing
- Medical management
- Good Clinical Practice
- Medical monitoring
- Aggregate reporting
- Global Safety Surveillance
The Medical Writer
The term “medical writing” encompasses different kinds of work for clients in media, government and industry. Given the volume of information that comes out of a clinical trial, there’s a lot to write about.
Pharmaceutical companies, hospitals, and other clinical trial sites, government agencies, and marketing companies (also known as medical communications companies) employ medical writers.
Pharmaceutical companies, medical-device manufacturers, and clinical-research organizations (CROs) all employ writers to prepare regulatory documents used to seek U.S. Food and Drug Administration (FDA) approval for drugs and devices.
Medical writers help doctors write research articles, monographs, and reviews on medical topics. Continuing medical education (CME) companies employ medical writers to produce educational materials and slide kits that doctors and nurses use to prepare for license renewals.
Medical writers produce sales training materials, press releases for industry, and fact sheets or Web site materials for government organizations. They also write about research discoveries for medical journals, Web sites, newsletters, magazines, newspapers, and any other medium that includes coverage of health and medical issues.
Regional Medical Advisor (RMA)
The Regional Medical Adviser (RMA) organizes unbiased interaction between the sponsoring company and the medical community. They communicate important medical information between the sponsor and the medical community. They will work with the marketing department to insure that information is accurate. The RMA fosters collaboration with Key Opinion Leaders to improve trial development, review and post-trial follow-up. The RMA is an important resource to provide answers to medical, regulatory and legal questions concerning the trial.
The roles of RMA and Medical Science Liaison (MSL) overlap significantly.
This position requires a medical degree (foreign degrees are often acceptable) and excellent leadership and organizational skills.
The Medical Science Liaison (MSL)
The Medical Science Liaison (MSL) is healthcare professional, usually with an MD or PhD, who has in-depth knowledge of the sponsor’s products, often related to one or a few therapeutic area(s) or product class(es). The MSL works as the communication interface between the pharmaceutical company and the medical community, working to help doctors and pharmacists understand their products. MSL are not involved in marketing, but are present to facilitate understanding for prescribers and users of the product. As such, the MSL is a spokesperson for the product and an educator who tries to relay information in an unbiased manner.
The MSL is involved in:
- Gathering new information about a product, including AEs and risks
- Medical training and information sessions
- Forming professional relationships with the medical community, regulatory agencies, investigators and key opinion leaders.
The roles of the MSL overlap significantly with those of the RMA.
Medical Affairs Manager
Medical Affairs (MA) is a title with a general scope. MA involves post-marketing activities related to healthcare products. Although this department is involved with commercial products, it is intended to provide objective support for clinical and scientific activities. Like the positions of Medical Science Liaison and Medical Advisor, which can fall into the category of MA, jobs in MA involve interacting and forming relationships with stakeholders and key opinion leaders. MA professionals are those individuals who represent the medical face of the company and who should be detached from promotional and marketing activities.
The collective goal of MA is to establish scientific credibility and long-term integrity with relevant scientific, academic and regulatory groups. Communication and leadership abilities are key to advancement.
Positions under the umbrella of MA include MSL, Medical Advisor, Medical Information Officer, Medical Affairs Pharmacist, Medical Director, Medical Lead and many others.
The IRB Associate
An IRB Associate contributes to the oversight of a clinical trial by helping to review proposed protocols or with any administrative duties related to this task. To work for an IRB, the individual must have a thorough understanding of all applicable regulations, particularly with Good Clinical Practice and regional regulations (including the Code of Federal Regulations in the USA). In addition, the candidate must be an objective, highly-principled who works well in teams and exercises good professional judgement.
Clinical Research Career Days
Career change is an important step and requires well-informed decisions. The CRA School has the mission of helping highly-qualified professionals in their career reorientation to new fields that fits their competences. Free consultations are provided by phone and Skype, or every week on Tuesdays @ 2:30 PM & Thursdays @ 5:30 PM, at #101- 405 Ogilvy av. Montreal (Please call to confirm an appointment).
The CRA School is member of the Access Pharma Group, which organizes special networking events every few months, where 3-4 seasoned pharmaceutical specialists and/or top managers with different professional background and from different companies speak about their jobs. They present career opportunities in the field of drug development, clinical research, quality assurance and regulatory affairs in the pharmaceutical industry, share their experience and give advice on how to enter in this rewarding field.
The objective is to give the attendants an opportunity to learn about the different career opportunities in the regulatory affairs field and to ask any questions to seasoned professionals. This is the best way to get unbiased answers directly from industry insiders.
For those who consider a career change, these networking events are a perfect opportunity to get first-hand answers to all important questions and make a well informed decision. To register for the next event, see our announcements on our home page.
To enroll with CRA School Montreal, please fill in the application form by clicking on the 'Enroll Today' button.
Aigul Iskakova, MD, CCRA, RA
Alma Ata, Kazakhstan.
Serguei Kalynych, PhD, CCRA, MSL
Brno, Czech Republic.
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Montreal, QC H3N 1M3, Canada
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