More about Clinical Trials Research

 

Definition of a Clinical Trial

According to the National Institutes of Health Office of Science Policy, clinical trials are defined as:

  1. A research investigation involving human subjects that is designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug, treatment, or device).  

  1. A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

 

How the Clinical Trials Research Associate (CTRA) Prepares Students

During the program, students obtain knowledge in basic product development, regulations, good clinical practice, and processes necessary to conduct a clinical research trial. Specifically, students in the program learn all aspects of conducting a clinical trial including the process for bringing a product “to market”, the individuals involved in conducting a clinical trial, and working with clinical research data.  They also learn the regulations that are defined by the FDA to conduct such trials. The program emphasizes ethical treatment of clinical research participants and teaches about various ethical doctrine, informed consent, and ethical conduct of clinical trials.

The material is taught from several different perspectives including, the pharmaceutical/medical device/biotechnology sponsor initiating and overseeing the trial, the research site that conducts the trial, the data management personnel who work with and “clean” the data etc. Students also learn about other types of clinical research including non-product interventional studies and observational research.

 

Post-Graduate Opportunities

The CTRA program prepares graduates for a variety of entry-level positions. A few of these positions are noted below. Jobs in the clinical research industry may be categorized as follows (please note that these categories, positions, their responsibilities and job qualifications will vary from company to company):

  • Clinical Research (Clinical Operations) – Individuals who work in clinical operations generally work with the design, initiation, conduct, and follow up of clinical trials. These individuals may work for pharmaceutical, medical device or biotechnology companies; contract research organizations (CRO), or the research site.
     

  • Contract Research Organization (CRO) or Pharmaceutical/Medical Device/Biotechnology companies – Many individuals get their first jobs with a CRO and it is very important to get this kind of experience. CRO’s are companies who support the work of the Pharmaceutical/Medical Device /Biotechnology companies.  These individuals interact with the research sites and work with the data.  Positions include (but are not limited to) research assistants, clinical research associates (CRA’s), clinical data managers, regulatory associates, site start-up specialists, project managers etc. They perform many functions including investigator selection, review and maintenance of study documents, ensure the accuracy of the data, ensure the adequate conduct of the trial according to federal regulations, correspond with research sites etc.
     

  • Research Sites (hospital, academic medical center, independent research site/clinics) are where the clinical trial is generally conducted. Positions available may include research assistant, study coordinator, or clinical research associate. These individuals work with the clinical trial participants and assist in collecting clinical trial data.
     

  • Clinical Data Management – Individuals working in clinical data management, review clinical protocols and identify what data are necessary to obtain during a clinical research study. They may also be responsible for correcting and “cleaning” the data by querying the research/study site and assisting with verification and analysis of the data. Common positions include data assistants or data managers.
     

  • Regulatory Affairs – Clinical research is a highly regulated industry. The work of clinical research professionals must be conducted in compliance with Federal regulations and, if the clinical trial sites expand globally, each country site’s regulatory regulations must also be followed. Many companies have a department that handles the regulatory aspects of the clinical trial, and for the entire development program for the product that is being studied. Individuals working in this area may interact with the FDA and other global regulatory agencies, ensuring that all trials are conducted according to FDA and local specifications, working with study documents, and marketing applications.
     

  • Product Safety/Pharmacovigilance – Individuals working with product safety/pharmacovigilance may be responsible for working with the safety information that is learned about a product. During a clinical trial, information collected about “adverse events” must be reviewed to ensure its accuracy. Any errors and “gaps” in the information must be resolved. This information is consolidated, analyzed and becomes an important part of an application to gain marketing approval of a product. Positions in this area generally require some medical background, such as nursing, and may require clinical research experience.
     

  • Quality Assurance/Auditing – Individuals working with quality assurance and auditing ensure that all research activities are conducted in accordance with applicable FDA regulations, guidelines, clinical trial specifications etc. This is accomplished by performing independent reviews of various aspects of clinical trials. These positions often require clinical research experience and special training.