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What is a Clinical Trial?
According to clinicaltrials.gov, a service of the U.S. National Institutes of Health, clinical trials, often referred to generally as “clinical research” are “biomedical or health-related research studies in human beings that follow a pre-defined protocol” (http://www.clinicaltrials.gov/ct2/info). Clinical trials may include interventional or observational studies. Specifically, a clinical trial may study the use of a product in human participants for the purposes of obtaining marketing approval of a product so that a physician can prescribe it. In this case, a clinical trial is a research study, in human subjects/participants, of a drug, medical device, biologic (such as a vaccine) or treatment. We generally conduct clinical trials on these products to determine if they are safe and effective for use by the general population. Oversight of these products is the responsibility of the Food and Drug Administration (FDA). Therefore, clinical trials are also under the FDA’s jurisdiction and oversight.
What will the Clinical Trials Research Associate (CTRA) program teach me?
During the program, students obtain theoretical 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 imposed by the FDA to conduct such trials. The program emphasizes ethical treatment of clinical research participants and teaches about various ethical doctrine, informed consent, ethical conduct of clinical trials and research in special populations.
The material is taught from several different perspectives including, the pharmaceutical/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. The program now offers a specialized certificate in Clinical Data Management.
What will the Clinical Trials Research Associate program prepare me to do?
The Clinical Trials Research Associate program prepares individuals to assist investigators and clinical researchers in the initiation, administration, coordination and management of clinical research trials for the development of new drugs, devices, biologics and treatment regimens.
The student applies this knowledge in a variety of venues such as a research site (including medical centers and hospitals), a pharmaceutical, device or biotechnology company or a contract research organization (CRO). Experiences may include recruitment and enrollment of human subjects, administering informed consent, review of study documentation, correspondence with research sites, working with research data etc.
What jobs are available in Clinical Research?
The DTCC CTRA program can prepare individuals 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 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 the Pharma/Device/Biotech company or contract research organization (CRO) or the research site.
• Pharmaceutical/Device/Biotechnology company or contract research organization (CRO) – CROs are companies who support the work of the Pharmaceutical/Device /Biotechnology companies. Many individuals get their first jobs with a CRO and it is very important to get this kind of experience. 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), 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) are where the clinical trial is generally conducted. Positions available may include that of a research assistant, study coordinator, or clinical research associate. These individuals work with the clinical trial participants and generally assist in collecting clinical trial data.
Clinical Data Management –Individuals working in clinical data management generally obtain the data collected during a clinical research study and is responsible for entering it into a database, correcting and “cleaning” the data by querying the research 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 many rules based on federal laws. 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 regulatory agencies, ensuring that all trials are conducted according to FDA 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, we obtain information about “adverse events”. This information 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.
Medical Writing – This area prepares multiple documents required for clinical research. These documents might include clinical research protocols, study reports, safety narratives and reports or regulatory submissions to the FDA or other agencies. Positions in this area generally require experience and specialized training.
Biostatistics – Play a critical role in the review and analysis of clinical trial data. These individuals provide critical input into how the data should be collected, analyzed and reported. These positions require extensive education, training and experience in biostatistics.
These are just a few of the areas where clinical research positions may be found. Please note that there are many others and you may see these areas broken down differently depending on the resource that you review.