Clinical Research

What is Clinical Research?

Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment. (Wikipedia, 31/10/19)

Clinical trials are research investigations in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions. Some investigations look at how people respond to a new intervention* and what side effects might occur. This helps to determine if a new intervention works, if it is safe, and if it is better than the interventions that are already available. Clinical trials might also compare existing interventions, test new ways to use or combine existing interventions or observe how people respond to other factors that might affect their health (such as dietary changes).

The World Health Organization (WHO) definition for a clinical trial is "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes".

Clinical trial interventions include but are not restricted to:

• experimental drugs

• cells and other biological products

• vaccines

• medical devices

• surgical and other medical treatments and procedures

• psychotherapeutic and behavioural therapies

• health service changes

• preventive care strategies and

• educational interventions.

Researchers may also conduct clinical trials to evaluate diagnostic or screening tests and new ways to detect and treat disease. (australianclinicaltrials.gov.au)

To work in the field, clinical researchers must have at least a degree with some positions requiring a PhD and relevant specialist experience. Employers include hospitals, universities, pharmaceutical companies, Clinical research Organisations (CROs), private companies and government departments. Key skills are critical thinking, attention to detail, complex problem solving and decision making, along with excellent numerical, written and verbal communication skills.

Overall, the role of a clinical researcher if employed by a pharmaceutical company or CRO may involve writing drug trial methodologies (protocol) including designing trial materials, briefing the team of investigators with instructions on how to conduct the trials, setting up trial study centres, authenticating case report forms and monitoring overall progress throughout the trial. (New Scientist Jobs, 8 May 2019)

The role of a clinical researcher if employed by a hospital or university may include writing drug trial methodologies (protocol) including designing trial materials, conducting the trial according to the protocol, recruitment of participants, performing study related procedures and assessments and maintaining clinical trial documentation.

Typical Clinical Research job titles

• Biostatisticians        

• Clinical Operations Directors        

• Clinical Operations Managers        

• Clinical Project Directors        

• Clinical Project Managers        

• Clinical Research Associates        

• Clinical Research Consultants        

• Clinical Research Directors

• Clinical Research Managers

• Clinical Research Nurses

• Clinical Research Physicians

• Clinical Trial Assistants

• Clinical Trial Coordinators

• Clinical Trials Pharmacists

• Clinical Trials Recruitment Managers

• Data Managers    

• GCP Auditors

• GCP Quality Assurance Associates

• GCP Quality Assurance Managers

• Medical Writers

• SAS Programmers

• Senior Clinical Research Associates

• Senior Study Start-up Associates

• Study Start-up Associates

• Study Start-up Managers

What are potential workplaces?

Pharmaceutical industry including biotech, complementary medicines sector
Medical technology industry
Universities
Clinical Research Organisations (CROs)
Hospitals
Clinical research institutes and organisations

Which degrees lead into a career in clinical research?

Bachelor or Masters degrees or PhD in:

Biomedical Sciences
Pharmacy
Pharmaceutical Sciences
Nursing
All major universities in capital cities should have degrees that qualify for a career in clinical research.

How ARCS can help

If you are thinking about a career in clinical research, ARCS is offering a range of workshops addressing essential requirements to set you up on your preferred career path.

Where to go and who to contact for more information?

Monitor some of the job search portals and search for Clinical Research positions. This should give you a better idea of what roles are available and who is recruiting. ARCS provides a job listing service in the weekly Member News (for ARCS member only).

Identify potential employers by type: hospital, research institutes and CROs or companies and approach them directly about entry level positions or graduate programs. There are a range of specialised recruiters for careers in clinical research.

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