It is common to think that clinical research occurs exclusively in labs where scientists perform experiments using test tubes and Petri dishes. Clinical Research is a field where we are testing new treatments, drugs, devices and therapies in humans. And while lab work can be one component, Clinical Research goes far beyond laboratory work. From early-stages of testing new drugs to large-scale clinical trials, this thriving and incredibly rewarding industry covers the full gamut of studies that aim to find new life saving and life changing treatments to improve human health.
Clinical researchers work in hospitals, universities, and research institutions, collaborating with doctors, nurses, patient advocate groups, and other healthcare professionals. They also work at Pharmaceutical companies, Contract Research Organizations (CROs) and vendors and their work involves gathering data, analyzing results, and developing new treatments and therapies that can substantially improve the quality of life for patients worldwide. In this blog, we’ll discuss the roles in Clinical Research and some of the unique challenges that can arise in clinical trials.
Roles in Clinical Research
Clinical research is a vital part of the healthcare industry that seeks to improve human health through various studies and trials. It is true that clinical research often involves patient-facing roles such as doctors, nurses, and clinical research coordinators, but other non-patient-facing roles also play a crucial role in advancing medical knowledge and improving patient outcomes.
Clinical Research Coordinator: Research coordinators play an important role in clinical research and their work is both with the participants (patients) in the trial and they work with data, information and regulatory.They are responsible for recruiting and enrolling participants, collecting and managing data, and ensuring compliance with regulatory guidelines for clinical trials. As part of their work, they frequently work closely with the study’s principal investigator, other research staff, and regulatory bodies to ensure compliance with protocol and participant safety.
After training with Clinical Research Fastrack, Awasi was hired as a CRC at The University of Arizona. With our training, he finally received the job support and career coaching he needed to land his dream role.
Clinical Data Manager: A data manager is another non-patient-facing role in Clinical Research. These professionals design, implement, and maintain the data management systems used to collect, store, and analyze clinical trial data. Their primary responsibility is to support study teams in the entry, tracking, and reporting of accurate data, as well as maintaining data integrity throughout the study. Additionally, they contribute to developing the databases and software tools used in analyzing and reporting study results.
Once Esther graduated from our training program, she was hired as a Data Coordinator at MD Anderson. With Clinical Research Fastrack’s training, Esther gained confidence and felt empowered to advance her career.
Clinical Research Associate: The role of a Clinical Research Associate (CRA) involves monitoring and overseeing clinical trials. By working with investigators and study coordinators, they ensure that Good Clinical Practice (GCP) guidelines and the study protocol are followed. It is the CRA’s responsibility to ensure that the trial is conducted ethically and that patient safety is maintained. Additionally, they ensure that all data is accurately recorded and reported and that the trial adheres to federal regulations. Training study staff, monitoring study budgets, and communicating with the trial sponsor may also be the CRA’s responsibilities. The work of a CRA is crucial to the success of clinical trials and the development of new therapies.
Clinical Research Fastrack provided the tools, knowledge, and job support Michelle needed to get hired as a CRA at PPD, a part of Theromfisher. With her background as a nurse and the core competencies she gained through our training program, Michelle is thrilled to be able to bring the added value of her new skill set and utilize it to help others in this rewarding field.
Regulatory affairs specialist: These professionals ensure that clinical research complies with federal, state, and international regulations. They ensure all required documentation is submitted in a timely manner and that the study is conducted according to good clinical practices. During the course of the study, they also act as a liaison between the study team and regulatory agencies, helping to resolve any issues that arise during the course of the study.
Once she completed her training with Clinical Research Fastrack, Mika was hired as a Regulatory Specialist at ECIR. Despite feeling as though she could get her foot in the door with her educational background, upon graduating, Mika realized there were gaps in her knowledge. With our training, she received the tools she needed to stand out in a job interview and start her career in Clinical Research.
The field of clinical research is multifaceted, requiring the contributions of many different professionals, including non-patient-facing roles. The success of clinical trials and the advancement of medical knowledge depends on these roles. Many treatments and therapies that we rely on today would not be possible without the work of research coordinators, data managers, research assistants, and regulatory affairs specialists.
Common Challenges Faced in Clinical Research Trials
Unlike lab research, clinical research involves human subjects, which poses unique challenges. Informed consent is one of the main challenges. Providing informed consent is essential for an ethical study, as it ensures that participants understand the risks and benefits of participating. The process of obtaining consent can be lengthy and challenging, especially for participants who may have limited literacy or language skills, or who are incapacitated. Proper training in the informed consent process is critical to the role of a professional executing this function.
Variability among human subjects is another challenge. It is often difficult to control all the variables that may affect the outcome of a human study, unlike lab research where conditions can be tightly controlled. Several factors can influence a study’s results, including genetic variations, lifestyle factors, and disease progression. Furthermore, it can be challenging to find participants for studies, especially for rare diseases. In clinical research, long-term follow-up is often required, which adds time and cost to the study. Studies involving children or older adults can be particularly challenging, as they may not be able to participate for long periods of time.
The collection and management of clinical research data is another challenge we face as clinical research professionals. The data collected in clinical research is often collected in various settings and may be of variable quality, unlike data collected in lab research. The privacy and security of participants’ data are paramount concerns in clinical research and must be rigorously protected. For studies to be ethical and safe, and for results to be valid and reliable, careful planning and execution are essential.
Why Choose Clinical Research Fastrack?
Clinical Research is an exciting field where we are advancing medicine. We are testing new treatments that once approved by the FDA can be life changing for patients. Being part of the field that is creating the future of medicine is challenging and stimulating work.
In the Clinical Research industry, it is crucial that professionals have a thorough understanding of the regulations and best practices necessary to break into the field and effectively conduct clinical trials. Gain the knowledge and the tools you need to succeed in Clinical Research with Clinical Research Fastrack’s accelerated training program designed and you will land your dream role in this industry, sooner.
At Clinical Research Fastrack we care for our students and work with each one to provide the support you need. Along with the immersive curriculum we provide, we also prepare our students with their job search , and we will connect you to professionals in the field. We are excited to help our graduates transition into a life-long career of learning, growth and discovery. Discuss the opportunity with a member of our team to learn if a career in Clinical Research is right for you!