Welcome to the exciting world of Clinical Research Technicians (CRTs) and their critical role in clinical trials. In the realm of pharmaceutical drug development, these professionals are indispensable, ensuring the smooth conduct of clinical trials from inception to final data lock. They are the unsung heroes working tirelessly behind the scenes, their work often going unnoticed yet profoundly impacting our communities. This blog will delve into whom clinical research technicians are, their responsibilities, qualifications required, and how they contribute to the crucial stages of drug development.

As a full service Clinical Research Organization (CRO), BioPharma Services experts participate in clinical trials from inception to final data lock. We specialize in conducting early phase (Phase 1), Bioequivalence (BE) and Bioavailability (BA) trials with healthy, special and patient populations, and offer an innovative approach to study designs in clinical trials in support of pharmaceutical drug development projects around the world.

Clinical Research Regulations:

All clinical trials require review and approval by an independent Research Ethics Board (IRB). This is a necessary measure regardless of the investigational product being tested, design or rationale of the study. For clinical studies taking place in Canada, both Health Canada and the IRB are required to review all applications to determine if the study can be conducted.

These regulatory bodies will review the clinical trial protocol and Informed Consent Form closely to ensure participant safety is the primary focus. Without the approvals from these regulatory bodies, studies are not permitted to run in Canada. To ensure we meet the requirements, our Clinical Operations and Medical Writing Teams work closely with these regulatory bodies to ensure that these trials meet the necessary standards.

Who are Clinical Research Technicians?

With safety at the forefront, hosting participants during clinical conduct is one of the most important components of these projects. Our staff responsible for the safety and well-being of our participants as well as the integrity of our study includes our certified Clinical Research Technicians (CRT’s).

Clinical Research Technicians (CRT’s) are individuals who have successfully acquired a Certified Lab Technician/Assistance designation, completed phlebotomy certification/training, and successfully passed both a written and verbal exam. Clinical research technicians are governed under the Medical Laboratory Professionals’ Association of Ontario (MLPAO). The MLPAO program consists of both theory based and hands-on training. This includes off-site practicums to provide students with a well-rounded education. 

Should the students choose to complete their practicum at a CRO, they are given the opportunity to interact with participants and expand their understanding of the important role CRT’s have when working in clinical research. During their practicum, CRT students are given the opportunity to learn how to perform a variety of medical procedures and laboratory techniques including sample processing and collection, ECG’s and vitals while under the supervision of qualified health care professionals. 

Successful graduates write an exam and attain a Certified Lab Technician/Assistance Designation through the Canadian Society of Medical Laboratory Services (CSMLS) and/or the Ontario Society of Medical Technologists (OSMT). They graduate with the skills, training, and knowledge to work in medical laboratories, hospitals, blood donor centers, clinical research organizations, and more. Their education and hands on placements prepare them to play an important and supportive role within the healthcare community. Other career paths individuals with this diploma can work in include, Medical Laboratory Technologist, Medical Laboratory Assistant, Phlebotomy Technician, Patient Service Assistant, etc.

What Qualifications/Education Do Lab Clinical Research Technicians Require?

• • OSMT Certification
  • Verbal test
  • Written test
  • BLS certification
  • Venipuncture – Phlebotomy certification

How do Clinical Research Technicians Contribute to Clinical Research Studies?

Here at BioPharma Services, our clinical research technicians can take on various roles during a clinical trial including monitoring participants for safety related concerns, documenting data accurately and ensuring proper safety measures are in place. Our CRT’s work in tandem with our Safety Team (consisting of physicians, registered nurses, registered practical nurses, medical assistants, physicians’ assistants) and are responsible for ensuring clinical trials run efficiently and prioritize study participant safety. Everyone plays a key role in providing a safe and comfortable environment for our participants during our clinical trials.

Tasks our clinical research technicians may be assigned to include, but are not limited to the following:

• • Preparation of Sample Collection Tubes
  • Sample Collection (Ex. Blood, urine, saliva, etc.)
  • Sample Processing/storage/Shipping
  • Study specific tasks (Ex. pupillometry, saliva collection, etc.)
  • Electrocardiograms
  • Vital Signs (Ex. Blood Pressure)
  • Meal Distribution
  • Documentation
  • Drug Administration Verification
  • Check In Procedures (Ex. Bag Search, Alcohol/Drugs of Abuse testing, etc.)
  • Participant belongings search
  • Mouth check following study drug administration
  • Meal monitoring
  • Sample collection tube preparation
  • Clinic set up
  • Decontamination of workstations, etc.
  • Proficient in study protocols and standard operating procedures

All tasks are extremely important and require a great deal of training, planning, and attention to detail as the data collected from these tasks provide important information that is crucial to the success and integrity of a clinical study. Once the documentation supporting these tasks is complete, it is sent to our Bioanalytical Lab, Clinical Data Management and Scientific Teams where samples are analyzed, data is inputted, and trends are tracked. The information gathered then provides insight into the success of the study drug before being available for mass production. If the results are deemed successful, the drug moves on to the manufacturing stage and is distributed accordingly.

The work performed by clinical research technicians contributes to the development of drugs that go on to treat various health ailments such as diabetes, dementia, hypertension and Alzheimer’s, etc. Most individuals who choose this career path do so because their work positively impacts the community and advancement of these drugs used to treat patients.

BioPharma Services’ Student Placement Strategy:

BioPharma Services partners with credible post-secondary institutions to provide students with practicum placement opportunities. These placements allow students to gain hands-on experience as part of their curriculum requirements. Most of the roles that we provide opportunities for are within the Clinical Research field such as Clinical Research Technician, Clinical Research Coordinator, and Clinical Screening Technician. Some of the schools that we partner with are the Academy of Applied Pharmaceutical Sciences, Anderson College, Evergreen College, and Oxford College. 

Students connect internally with their schools’ Placement Coordinator to arrange the placement with BioPharma Services. BioPharma Services confirms availability for hosting students and arranges for their onboarding. Students complete many duties and responsibilities of a full-time employee to ensure their experience is valuable and contributing to their learning and growth. We provide students with training, guidance, and mentorship to set them up for success throughout their professional development journey. Providing students with these opportunities is valuable to us as an organization, and we look forward to continued partnerships in the future.

 Written By: Stephanie Correia, Director of Clinical Research.

BioPharma Services, Inc., a Think Research Corporation and clinical trial services company, is a full-service Contract Clinical Research Organization (CRO) based in Toronto, Canada, specializing in Phase 1 clinical trials 1/2a and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma conducts clinical research operations from its Canadian facility, with access to healthy volunteers and special populations.