Clinical Research refers to all research and clinical trial processes carried out on humans to determine the safety and effectiveness of treatments intended for human use. Clinical Research improves the knowledge of diseases, developing diagnostic methods and new treatments or medical devices to ensure better patient care.
Clinical Operations refers to the team or department that is responsible for the delivery of the clinical trials. It is their task to design, plan and physically run the four phases.
Pharmaceutical companies may conduct these clinical trials on site, or they may have an agreed partnership with an external Contract Research Organisation (CRO), who will conduct the trials on their behalf.
A career in clinical research involves conducting scientific studies and trials to investigate new medical treatments, drugs, devices, and therapies. Clinical research plays a crucial role in advancing medical knowledge and improving patient care. It involves a multidisciplinary approach that combines medical, scientific, and ethical principles.
Clinical Research Coordinator (CRC): CRCs are responsible for the day-to-day management and coordination of clinical trials. They work closely with principal investigators, sponsors, and study participants to ensure that the study protocols are followed, data is collected accurately, and all regulatory requirements are met.
Clinical Research Associate (CRA): CRAs are field-based professionals who monitor clinical trials at investigative sites to ensure compliance with protocols, regulations, and good clinical practices (GCP). They conduct site visits, review study documents, and communicate with site staff to ensure data integrity and participant safety.
Clinical Research Manager/Director: These professionals oversee the planning, execution, and completion of clinical research projects. They are responsible for ensuring that projects are conducted within budget, on time, and in accordance with applicable regulations and guidelines.
Medical Science Liaison (MSL): MSLs act as bridges between pharmaceutical companies and healthcare professionals. They communicate the latest scientific research, clinical trial data, and medical information to healthcare providers, answer their queries, and engage in scientific discussions.
Regulatory Affairs Specialist: Regulatory specialists are involved in the submission of study protocols and data to regulatory authorities for approval. They keep abreast of the constantly evolving regulatory requirements and ensure that all necessary approvals are obtained.
Biostatistician: Biostatisticians use statistical methods to design studies, analyse data, and interpret study results. They help determine the appropriate sample size, assess data quality, and draw meaningful conclusions from study findings.
Ethics Committee/IRB Administrator: These professionals are involved in the ethical review and approval of clinical trials. They ensure that the rights and well-being of study participants are protected and that the study adheres to ethical principles.
Medical Writer: Medical writers prepare study-related documents, including clinical study reports, protocols, and informed consent forms. They must effectively communicate complex medical and scientific information in a clear and understandable manner.
To pursue a career in Clinical Research, individuals typically need a relevant educational background in life sciences, medicine, pharmacy, nursing, or a related field. Gaining experience through internships or entry-level positions can be beneficial for career advancement. Additionally, certifications such as the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA) can enhance one's credentials and marketability.
It's important to note that clinical research can be intellectually stimulating and rewarding, as it directly contributes to medical advancements and improved patient outcomes. However, it also demands attention to detail, adherence to rigorous protocols, and a strong commitment to ethical conduct to ensure the safety and well-being of study participants.
Clinical Research roles most commonly operate within pharmaceutical companies or contract research organisations (conducting clinical research on behalf of pharmaceutical companies). They can also work closely with hospital departments focussing on collecting information about drugs.
If you have a background within life sciences then a career in Clinical Research/Operations could be an exciting and rewarding opportunity for you. You’ll be working on one of the most important aspects of the drug development cycle and such responsibilities typically come with an excellent pay package.
Working within Clinical Operations opens the door for a career across the whole breadth of the clinical research network. Working within clinical trials means you’ll meet a whole host of industry experts, which could result in opportunities for you further down the line.
Starting in a junior level role, you’ll most likely find yourself quickly moving up the ranks until you reach Clinical Director / Clinical Operations Lead level. Here, you’ll be responsible for the overall running of a trial.
To get a job as Clinical Research Associate you will be required to have an undergraduate degree and/or postgraduate qualification in medical sciences, life sciences or nursing. Relevant subjects include:
Although a PhD isn’t always necessary to attaining a job in Clinical Research, it can sometimes be advantageous and employers may view this as relevant work experience and you may able to progress into higher paying roles quicker. Starting salaries for Clinical Research Associates, for example, tend to range between £25,000 and £30,000 PA. After a few years of experience, Senior Clinical Research Associates can earn upwards of £35,000 to £50,000 plus.
In terms of experience, other than a PhD, it can be beneficial to have undertaken some work within a hospital, pharmaceutical company or CRO during university through a year in industry or short/summer placement. Without this, though, it is possible to get into a lower level role and progress further.
Find out more about how to progress your Clinical Operations career here.
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