Additional responsibilities may include identifying eligible patients, scheduling and escorting patients from different venues, obtaining informed consent from patients, performing tests, entering data into a database, verifying data integrity, performing basic statistics, and helping to prepare presentations and assist with article writing. In addition, the CRC may be charged with compliance to Institutional Review Board (IRB)-approved research protocols and applicable federal, state, and local laws and regulations. They must complete all required human research training and, if applicable, training required by the Health Insurance Portability and Accountability Act.
Explore This IssueApril 2015
Clinical coordinator. While this position may have some overlap with the research coordinator, the clinical coordinator tends to have some medical training, either as a nurse or physician assistant. Additional skills allow this research assistant to perform more studies on patients.
Statistician or methodologist. This team member will ensure that the PI develops a methodologically sound protocol that is appropriately powered to answer the primary research question. Usually possessing a master’s or PhD level of training in biostatistics, this person has expertise in research methodology, helps to analyze the data, and is integral to the design and execution of the study as well as evaluating the integrity of the study after it is finished. The PI or a co-investigator can often handle this function.
Recruitment is 80% to 90% of the work in a clinical study. Your own patient population (or that of your co-investigators) is a great resource. “Plan on contacting at least twice as many patients as you think you will need,” said Judith E. C. Lieu, MD, MSPH, associate professor of otolaryngology-head and neck surgery and residency program director at Washington University in St. Louis School of Medicine. “Unless the study is looking at a rare disease or an intervention where none existed previously, where a higher percentage of patients may be interested in research, many patients will not choose to participate. Patients are free to participate or not and have the option of changing their mind and not completing a study. Even when they are excited about participating, the logistics can be an obstacle.”
It is important to let patients know that participation in research projects is voluntary. “Let patients know that they will continue to receive the same access to medical care whether or not they choose to participate and that they may withdraw from participation at any point,” said Dr. Strychowsky, whose research has revolved around evidence-based practice, systematic reviews and meta-analyses, and outcomes-based research in pediatric otolaryngology.