What to Expect Working as a Clinical Researcher

Clinical research is a discipline within the broader field of health research that focuses on how to improve patient care through new treatments, procedures, and practices. Per the NIH, clinical research is at the heart of all medical advancements. Through clinical research efforts, promising advances in the health field can be studied for their effectiveness, safety, and feasibility. Clinical research is the mechanism for new ways of surgery to be studied, new medical devices to be tested, new uses for existing treatments to be discovered, among more. For example, findings from a recent study uncovered a new biomarker that may help predict cognitive decline in people with Alzheimer’s disease. Another recent study found that children who frequently consumed foods containing peanuts early in life had a reduced risk of developing peanut allergy. Clinical research is unique to other types of research studies because it uses human participants in its trials, so that data can be collected as evidence for regulatory approval. This model of using human participants in clinical research trials is called human subjects research, and is one of the most rigorous and regulated types of clinical research.

Clinical researchers are crucial to the introduction of health improvements, new and novel treatments, and interventions into the market. They are responsible for overseeing the design and organization of the trials, including developing protocols, participant criteria, and data collection methods. This can include tracking unexpected participant side effects, maintaining enrollment, and ensuring participant satisfaction. As the principal investigator (PI) of a study, this could also mean managing a staff of research assistants, Institutional Review Board managers, and data scientists, as well as collaborating effectively across departments and between organizations like healthcare companies, hospitals, funders, etc. As data is collected, clinical researchers conduct data analysis to determine if the intervention is statistically significant and effective in the clinical research world. 

Upon doing so comes communication of the study findings in a way that is absorbable by the public. Often, this includes developing manuscripts for publication or regulatory submissions. Along the way, researchers must ensure that each step of the research process adheres to strict ethical standards, such as maintaining Good Clinical Practice (GCP), which the NIH describes as the international quality standard in which investigators, sponsors, and monitors are responsible for the conduct of clinical trials. Most research organizations use the Collaborative Institutional Training Initiative (CITI Program), which is a nationally and internationally recognized expert in research ethics, compliance to train researchers, faculty, and students in areas such as research design and ethics, safety, and professional development. Common CITI Certifications for clinical research include Human Subjects Research (HSR), and Good Clinical Practice (GCP), though there are courses covering all areas of research compliance, professional development, and more. 

The ethical aspects of clinical trials are reviewed by the Institutional Review Board, or the IRB. The IRB, under the Food and Drug Administration (FDA), is a group that has the authority to approve, require modifications to, or reject study protocols on the basis of their obligation to protect human subjects and researchers. Once given IRB approval, the board will continue to review and monitor throughout the execution of the study to ensure consistent alignment with its ethical standards and procedures. Any study that involves human subjects must attain IRB approval. You can learn more information about the IRB and its processes here. 

There is no one path to becoming a clinical researcher. However, most professionals in the field have strong academic backgrounds in areas within the health sciences field such as biology, chemistry, epidemiology, biostatistics, or pharmacology. For more advanced positions, many researchers will obtain a Master’s or PhD in these areas. Some researchers go on to acquire their Certified Clinical Research Professional (CCRP) certification, which is an internationally recognized credential that enhances credibility, as it requires an examination testing a high level of knowledge and skill. This credential also ensures a commitment to standards, compliance, and integrity, and is highly valued within the clinical research community.

Similarly, many professionals may acquire the Certified Clinical Research Coordinator (CCRC) certification, per the Association of Clinical Research Professionals (ACRP), which recognizes clinical research professionals who have experience coordinating and facilitating clinical trials in alignment with GCP principles. The CCRC also requires passing a rigorous exam that demonstrates competency in specific knowledge areas surrounding clinical research practices. Similar to other areas of research, the best way to get involved is through hands-on experience in a clinical research setting. This grants opportunities to develop practical skills, like data collection and management, best practices when interacting with patients, experience with IRB development and submission, among more.

You can gain hands-on experience through pursuing internships, fellowships, or entry-level positions in clinical research settings- most commonly through working as a Clinical Research Assistant, Clinical Research Coordinator, or Clinical Research Associate. 

With a diverse range of career paths and opportunities for growth, individuals working in the field of clinical research make a positive impact on health and wellbeing through contributing to the advancement of new treatments and healthcare innovations. Entering the field through an entry-level position, such as a Clinical Research Associate or a Clinical Research Coordinator, will develop introductory skills surrounding participant recruitment, participant monitoring, and data collection. There’s an opportunity to advance into higher level positions over time, such as a Clinical Research Manager, and have increased levels of responsibility, including managing budgets or multiple studies simultaneously. Those with expertise in ethics, regulatory affairs, or quality assurance may move into specialized roles such as an IRB Coordinator, Regulatory Affairs Specialist, or Clinical Quality Analyst.

In conducting clinical research, there are always ethical considerations and obligations that researchers face. This can be challenging since research ethics are dynamic, and the field of ethics is constantly changing and evolving to ensure best practices are exercised to protect patients and researchers alike. For example, researchers must ensure superb informed consent practices, commit to patient confidentiality, and consistently ensure the ethical treatment of trial subjects.

Not only are these practices of high importance during the study, but afterwards there must be processes in place to protect patient data for the years following, which varies depending on the type of data and records collected. Similarly, the data must be collected, interpreted, and communicated in a way that mitigates any potential bias from the researcher or organization. However, these ethical considerations and obligations are monitored by the IRB, so researchers can ensure that they are consistently aligned with up-to-date best practices and procedures.

Clinical research is recognized to be at the core of medical advancements and innovation. International quality standards and guidelines have made it increasingly easy to collaborate with organizations, researchers, and scientists across the world. The global expansion of clinical research allows for an even greater pool of ideas, participants, and strategies. This increased collaboration is of benefit to the field of clinical research and its implications for international health policy and patient care.  Furthermore, new and emerging technologies, such as artificial intelligence and machine learning, may play a significant role in the analysis and interpretation of data.

New technologies are allowing new opportunities within clinical research, such as the remote monitoring of data collection, or the analysis of mass datasets, to potentially have monumental impacts on the efficacy and development of research findings.  Still though, the FDA must ensure that new technologies aimed to support clinical decisions are safe and effective. To do so, they are developing a Digital Health Software Precertification Program (Pre-Cert). This video is a great source to learn more about how the development of Pre-Cert, and how the FDA envisions the software being used in the future.

Clinical research plays a vital role in driving medical innovation and improving health outcomes. There are multiple pathways into the field, from gaining hands-on experience as a Clinical Research Coordinator or Associate to pursuing advanced degrees like a Master’s or PhD for more senior roles. Regardless of the path chosen, a strong commitment to ethical standards—protecting the safety and well-being of research participants—is fundamental. Overall, clinical research offers meaningful and impactful career opportunities, allowing professionals to contribute directly to advancements in patient care and healthcare practices.