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Adverse events refer to any negative patient reaction to a drug throughout the course of a clinical trial. Experience with monitoring and addressing adverse events is a critical skill for clinical trial professionals, as patient health and safety are on the line. Once patients are safe, analysis must take place to determine whether the adverse effect was a result of the drug or an unrelated condition.

A key procedure in the scientific process for biologists, assays are the process by which biologists measure and assess the presence and quantity of the target entities they're studying. Given how essential it is to the biologist's work, its a must-have skill set for job seekers in this field to learn.

In the field of clinical research, data management is less routine and more life-saving. Case report forms (CRFs) are documents used to collect individual patient data from a clinical trial to document patient reactions in the proper, regulatory-compliant format, and they're essential records when coming to a decision about a drug's safety.

Cell structure and function form the focus of this scientific skill set, and it's an essential one to learn for biologists interested in life at its most basic form. In addition to specializing in the study of cells, a knowledge of chemistry, physiology and biology is also helpful.

"Safety first" is the mantra for clinical research, and it's an important skill set to learn for anyone looking to start a career in life sciences. Clinical research involves the study of new medications to ensure their safety and efficacy before gaining approval for consumption by the general public.

Another key set of regulations for quality control specialists to keep in mind, corrective and preventative actions refer to guidelines imposed on clinical research organizations in order to eliminate what's known as "recurring nonconformance." This can usually be achieved by adjusting organizational procedures, documentation processes and other standardized processes to improve operations and keep them on track.

An ongoing process, drug safety reporting involves the monitoring of patient reactions throughout the course of the trial to eventually come to a determination about a drug's overall safety. Those compiling drug safety reports must also stay on top of all regulatory guidelines to ensure their drug meets current safety standards.

High standards of safety and quality don't end once the clinical trial is done. In this case, good manufacturing practices refer to the essential guidelines and quality standards drug manufacturers must meet for their products to be released to the market.

A lot of complex research and concepts go into leading and executing a successful clinical trial — and that’s where medical and technical writing comes in. Medical writing is needed to help convey complex trial results in easily digestible language for medical professionals or journalists to analyze and use. These skills are also used in the development of marketing materials and educational copy.

The study of life at the molecular level, molecular biology is an essential skill for aspiring biologists to master. Various strains of science converge in the molecular biologist’s skill set, with knowledge of other fields like chemistry, biology and physics also needed in order to become a well-rounded practitioner in this sector.

The process by which drug safety is ensured, pharmacovigilance is a key skill in occupations like regulatory affairs. Pharmacovigilance involves monitoring drugs to detect any previously undiscovered adverse effects and communicating data from their findings to the relevant regulatory bodies to ensure marketed drugs remain safe for human consumption.

Before a sponsor can officially award your site with a clinical trial, they’ll want to conduct a pre-study visit. Specialising in pre-study is a valuable skill set for clinical research associates to learn, involving steps like scheduling department tours, anticipating points of concern and outlining plans to address them to secure new business.

For a drug to secure approval, it not only needs to demonstrate safety and efficacy — it needs to demonstrate those qualities in a compliant environment. Quality control, in this context, involves monitoring standards throughout each phase of a clinical trial to ensure compliance with pertinent regulations and guidelines.

Site monitoring involves the oversight of clinical trials to ensure adherence to relevant regulatory guidelines and overall standard operating procedures. Site monitoring is one of the occupations under the clinical research umbrella that requires a solid blend of hard and soft skills, with project and people management needed to excel in this role.