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 Reseach 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 have to go to the office when not on the road and perform also some other administrative tasks if needed. Experienced field CRAs can work also 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 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, which 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 (reports show that research departments are often understaffed up to 25-30%)* 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 CRP (CRA/CRC) Certification program prepares Certified Clinical Research Professionals (CCRP) for many of the principal jobs in a clinical trial.
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 CRA/CRA certification course covers all jobs of interest both in pharmaceutical companies, in CROs, and in hospitals or University clinical research centers.
The Clinical Research Associate (CRA)
A CRA represents the sponsor company and ensures that proper procedures are followed during the complex, long, expensive clinical trials process.
The CRA position is the most popular way to enter clinical research careers, partly because such positions are relatively abundant.
CRAs are employed both by sponsor companies and by contract research organizations (CROs), companies engaged by pharmaceutical and biotech companies to help chaperone a drug through clinical trials.
Many CRAs enjoy the constant change and the variety of people and drugs they get to work with at a CRO, whereas others prefer to work for a drug company where they can follow a new therapy all the way through.
Either way, a CRA job is heavy in paperwork and requires good organizational and people skills. There’s always a lot of travel, as the CRA moves from trial site to trial site, monitoring the trials activities, coordinating documentation, and meeting with clinical investigators.
The Data Manager
The data manager and his or her team are the architects of systems that produce data. And because the product of clinical trials is data — lots of data — this job is an important one.
Before a trial begins, the data manager and her team review draft protocols for the study to ensure that the trial is designed from the beginning with accurate and precise instructions for those responsible for implementing the protocol. The team writes a trial’s data-management plan and confirms that all the reporting forms and data-transfer procedures make sense.
Once a trial is under way, the group reviews incoming data and maintains its database, ensuring that everyone is following the rules, then hands off the data to the biostatisticians for review.
The product of a trial – the data – has to be analyzed and interpreted when it starts coming back from the study sites. This is where the biostatistician comes in.
The U.S. Food and Drug Administration (FDA) will approve a product only if the data meets certain statistical criteria, so this position is very important in a trial’s success.
Sponsor drug companies use biostatisticians before a trial begins to help set parameters for data collection and review. But their main work is analyzing the trial data and extracting results.
Because statistics are known to be ‘massaged’ from time to time to suit the needs of a pharmaceutical company, this area of work is highly regulated.
The Clinical Quality Assurance Auditor
Clinical quality assurance (CQA) auditors inspect all documents and processes for a study to ensure that they all comply with the good clinical practice (GCP) guidelines and standard operating procedures (SOPs).
Today, studies are done all over the world, and there is increasing pressure to harmonize standards and procedures. The CQA auditor is in the thick of things in the regulated world of clinical studies, ensuring compliance with ever-changing rules and regulations.
Regulatory Affairs Careers
RA professionals come from a variety of disciplines such as law, academic/industrial research and medicine. RA is a promising field for scientists searching for alternative careers because it offers a multitude of starting jobs and opportunities for advancement.
RA professionals are essential to all aspects of the drug-development process including preparing, submitting, and monitoring submissions to regulatory agencies, addressing issues raised in the regulatory review process, managing reports, and tracking and other post-marketing functions.
However, RA professionals are increasingly involved with products during the research and development phases, in the design and monitoring of clinical studies, marketing, advertising, and communications.
They are also involved in aspects of manufacturing, packaging/distribution and business strategy, particularly as related to international regulatory submission strategies and policies.
The RA profession is typically the source of information on international regulatory issues, with a significant number of RA professionals monitoring and analyzing regulatory issues for multiple nations and regions of the world.
The RA professionals facilitate the collection, analysis, and communication about the risks and benefits of health products to regulatory agencies, medical care systems, and the public.
Operationally, RA is responsible for assuring that government obligations, market-driven demands, and evolving scientific conventions are understood and addressed by various stakeholders of the medical and health care system.
The Regulatory Affairs specialist
Regulatory affairs specialists work at the interface between business and government regulations, shepherding medical products from inception to market.
It’s a career track that can move you quickly from beginner to manager, reward you with weighty responsibility for important projects, and pay you more than what you would have earned if you had stayed at the bench.
However, a job in RA is also one of the most difficult transitions for a postdoc or graduate student. Not only is it difficult to land an entry-level RA job, it’s an incredibly demanding post.
The work is very detail-focused, as it involves writing and reviewing documents that are thousands of pages long. It requires an understanding of science and business, as well as government language and procedures.
The pressure can be intense–but it’s important work, and for scientists with the right mindset it can be an excellent career.
Jobs on this career track are found in all sorts of companies: biotech and pharmaceuticals, medical devices, diagnostics, cosmetics, and even nutritional products. The best way to learn more about RA, is to set up informational interviews with people who work in the field, or meet them at career events.
Clinical Safety Specialist
The clinical safety professional is responsible for monitoring, coding, organizing, and tracking adverse events that occur during a trial. The clinical safety person is really a patient advocate. He or she must track negative results that occur in a trial and ensure that each patient is given the appropriate medical care. The clinical safety specialist is responsible for reporting adverse events to FDA. Nurses dominate the field, although it’s possible for other degree holders to enter if they’ve had 2 to 4 years of clinical experience.
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 Authorisation 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
- 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 position of regional medical advisor (RMA) is relatively new in the pharmaceutical industry and its roles and responsibility are still evolving.
The RMA is a field based position whose main mission is to foster collaborative relationships with the key opinion leaders (KOLs) and to facilitate the exchange of unbiased scientific information between the medical community and the company.
Field-based medical liaison teams are expanding world-wide as part of the pharmaceutical industry’s increased focus on global operations including emerging markets.
The major objective of the RMA is to develop the professional relationships with the health-care community, particularly KOLs, through peer-to-peer contact.
The RMA can assist in the development, review, and follow-up of the clinical studies initiated within the relevant therapeutic area at the regional/local level.
The RMA can lead regional/local clinical projects to ensure that all clinical trials are conducted in compliance with the International Conference of Harmonisation Good Clinical Practice (ICH GCP) guidelines.
The Medical Science Liaison (MSL)
The Medical Science Liaison (MSL) is a specific role within the pharmaceutical, biotechnology, medical device, CRO and other health-care industries. MSLs have advanced scientific training and academic credentials generally consisting of a doctorate degree (Ph.D., PharmD., M.D.) in the life sciences.
MSLs concentrate on a specific therapeutic area (i.e. oncology, cardiology, CNS, pulmonary, hematology, surgery, women’s health care, etc) and disease state.
Medical Science Liaisons work throughout a product’s lifecycle, help to ensure that products are utilized effectively, serve as scientific peers and resources within the medical community, and are scientific experts to internal colleagues at companies.
However, the primary purpose of the MSL role is to establish and maintain peer-to-peer relationships with leading physicians, referred to as Key Opinion Leaders (KOLs) at major academic institutions and clinics.
This role is very similar to that of the medical advisor based at the corporate office in several ways except that it is normally field based and more marketing support orientated.
Medical Affairs Manager
Most pharmaceutical companies have two kinds of scientific teams: research / development and medical affairs. In small companies, the same team may be responsible for both kinds of activities.
While R & D defines the scientific direction and early-stage development, medical affairs provides scientific support for late stage development and post market support for drugs and devices.
Medical affairs usually functions alongside marketing, to provide technical support to both internal teams and external customers. The tasks involved are
- Informational services – the scientists and physicians working in medical affairs generally act as disease experts. Activities range from educating department members, seeing that consumer questions are addressed, and providing informational services to health care providers in the community.
Medical affairs also formulates publications plans, and the reporting of pivotal trial results to the FDA, at scientific meetings and through journal articles.
- Regulatory review – medical affairs works with regulatory affairs and the legal department to insure that all written documents are accurate and adhere to the guidelines mandated by the FDA. All educational, technical and promotion materials are reviewed.
- Liaison to health care professionals and professional organizations, and disease state advocacy groups. Medical affairs works to support the efforts of professional associations, patient support groups, and educational foundations.
- Thought leader development — this involves providing information and other supports to persons who are recognized experts in their fields.
- Educational meeting support — in the “olden” days, pharmaceutical companies actually wrote, staffed and sponsored continuing medical education events. Educational meeting support now only can be provided in the form of unrestricted educational grants.
- Supporting marketing — medical affairs provides the scientific input and expertise in the design and construction of all promotional materials and events. At the least, materials are reviewed by medical affairs for scientific accuracy. Medical affairs officers may also present relevant scientific information at marketing functions.
- R & D — depending on the structure of a company, medical affairs may also be responsible for all stages of clinical development including study design, initiation and monitoring. Medical affairs also may oversee the dispersal of funds and /or study drugs for investigator initiated trials.
- Post market drug safety functions – in some companies medical affairs handles drug safety, reviewing individual adverse event reports, aggregate adverse event statistics, and sometimes even talking with customers about drug safety. (In some firms, these tasks fall under the egis of regulatory affairs).
- Medical liaison – many companies have teams of medical liaison reps (MLRs) who are often field based medical information specialists, providing in depth drug and disease state information to health providers in their territories.
They function as colleagues and experts in their fields. (Note that some companies may employ medical sales liaisons (MSLs) who, while providing services like MLSs, work within the marketing department).
As you can see, medical affairs encompasses scientific, informational, communications and interpersonal activities.
A typical day is highly varied, starting, perhaps, with a medical legal review session, followed by meetings with marketing, then reviewing preliminary data with the statistics group, and then attending a protocol review committee.
A lot of time is spent in meetings and working in teams. If you are a reclusive lab rat type, medical affairs may test your people tolerance. It also helps to have a bit of an entrepreneurial bent, in order to understand the wants and needs of colleagues on the marketing side of the building. And much of the work depends on building relationships within and outside of the company.
The Clinical Research Coordinator (CRC)
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical study Principal Investigator (PI).
While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.
The clinical research coordinator reports primarily to the Principal Investigator with associated responsibilities to the department head, division administrator or program administrator.
The IRB Associate
The IRB (Institutional Review Board) Associate is responsible for managing the renewal review process and providing all aspects of workflow and administrative support to the IRB Panel.
The IRB Associate uses strong customer service skills, tact and good judgment to perform routine and advanced administrative duties requiring a high degree of accuracy and timeliness, in-depth knowledge of organization policies and procedures, and familiarity with the Human Research Protection regulations.
Support includes assisting users of the IRB eProtocol system; working with both internal and external groups on improving the eProtocol user experience; managing subsets of research protocol activities; interpreting, processing and tracking reviewer comments and investigator responses; timely and accurate preparation of files for panel review and audits; and interaction with faculty, public members, staff, students, visiting scholars to assure the studies compliance with applicable government and local regulations, as well as the organization’s policies and practices.
Clinical Research Career Days
Career change is an important step and requires to take a well informed decision. CRA School has a mission to help highly qualified professionals in their career reorientation to an unknown field 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.
CRA School is member of the Access Pharma Group, an association of non-profit organizations, which organizes every month a special networking event where 3-4 seasoned pharmaceutical specialists and/or top managers with different professional background and from different companies speak about their jobs. They present the career opportunities in the field of drug development, clinical research, quality assurance and regulatory affairs in the pharmaceutical industry, share their experience and give advices how to enter in this rewarding, but not very popular field.
The objective is to give the attendants an opportunity to learn about the different career opportunities in the regulatory affaires field and to ask freely all their questions to seasoned professionals, who are in the game, and in this 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. The register for the next event, see our News.
To enroll with the 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.