There’s no question that clinical trials are tremendously important. Without them, we would have no way of knowing if the medications we take and the treatments we undergo are safe and effective. Clinical research associates (CRAs) play a vital role in ensuring that the information garnered from such trials is reliable and that it is obtained safely, ethically and in compliance with investigation protocols. Fortunately, the field is growing and opportunities are abound!
“It’s a huge industry with exciting work, a variety of career paths and ample room for professional advancement,” says Aerotek Clinical Solutions Technical Manager, Christy Obercian
If you have a background in the sciences, are a good communicator, have good organizational skills and are interested in contributing to the advancement of medical science, a career as a clinical research associate may be for you. We caught up with Aerotek Clinical Solutions Technical Manager, Christine Obercian to find out about this thriving industry. Here’s what we learned:
What is the role of the CRA?
The CRA acts as a liaison between the physician conducting the clinical trial and the sponsor of the trial, which may be a government agency such as NIH or DOD, a pharmaceutical, biotechnology or medical device company or academic medical center. The CRA oversees the study from beginning to end making sure that everything is done correctly and runs smoothly.
What are the duties of the CRA?
The CRA visits the clinical trial site before, during and after a clinical trial to make sure that all protocols and GCP (Good Clinical Practice) guidelines and international, federal and local standards for clinical trials are being met. The CRA is also responsible for collecting and completing necessary paperwork, such as informed consent forms and SOP (Standard Operating Procedures) documents, keeping meticulous records, reviewing and analyzing study data, ensuring the well being of study subjects and negotiating solutions for any problems that arise in the course of the clinical trial.
What kind of education and/or training is required?
Most CRAs have bachelor’s degrees in nursing, pharmacy or life sciences. According to Study.com
, “Common courses that will prepare you for a career in clinical research include biochemistry, biostatistics, mathematics, epidemiology, anatomy and health care management.”
It is beneficial to get on-the-job experience by working as a clinical trial assistant, lab technician or clinical research assistant before applying for CRA jobs. Additional training in GCP is also necessary and can be obtained in a variety of settings. Graduate degrees are sometimes necessary for CRAs who want to move into supervisory positions such as project managers, directors or associate directors. Obercian notes that most CRAs receive ongoing training provided by their employers.
What are the skills and qualities CRAs need for success?
CRAs must be detail-oriented and well organized. While it’s important for CRAs to understand scientific concepts, it’s also critical for them to have strong interpersonal skills. CRAs must be able to communicate with doctors, researchers, sponsors, clients and vendors, and work within a matrix environment. CRAs must be able and willing to travel since they spend much of their time visiting clinical research sites throughout the country.
What are the prospects for career growth?
According to AcademicInvest.com
, “Although career structures vary from company to company, you can typically move up from an entry-level position in clinical research (such as clinical trial administrator, or junior research associate) fairly quickly depending on factors such as the proficiency of your skill set, your level of motivation, your previous experience, your level of education and many others.”
Obercian says that “a successful clinical trial or project manager will need to have knowledge of clinical trial execution, data management, biostats, medical writing and safety.”
Additionally, project managers should have good multi-tasking skills since they are often responsible for multiple trials at the same time, she adds.
What is the outlook for the profession?
According to U.S. News and World Reports’ University Directory
, “The BLS predicts employment in this field will grow much faster than the average for all occupations. Job growth will occur as the biotechnology industry continues to grow and as expansion continues in research related to diseases and the population’s increasing resistance to antibiotics.”
From Obercian’s vantage point in the field, the clinical research field is booming and CRAs are in high demand. “Once people enter the clinical research field, they usually stay there,” says Obercian. Yet that doesn’t mean they stay at one job for decades. “The field offers many opportunities both for upward mobility and diverse career tracks since CRA skills are transferable from one sector to another,” says Obercian.
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