Clinical Trials Practice

Clinical Trials Practice

Graduate Certificate in Clinical Trials Practice

This postgraduate degree course in clinical trials is designed to meet the educational needs of registered nurses and health professionals seeking to advance their careers in clinical trials. Working in clinical trials presents an exciting and challenging career pathway which is varied and diverse and successfully combines clinical knowledge with practical research skills. Nurses and other health professionals are critical to the successful conduct of clinical trials, the quality and integrity of trial results and their translation to practice. Acquiring the requisite knowledge and skills is an important stepping stone for all those involved in the conduct of trials and those pursuing a career in clinical research.

Background to Clinical Trials Practice

Clinical trials are a critical step in the development of new treatments and therapies across every field of medicine. At each phase of the clinical development pathway, from first in human (phase I) trials through to late phase marketing (phase IV) studies, clinical trials vary in their design and purpose and involve testing a wide range of interventions and observations including new drug therapies, medical devices, surgical and other non-pharmacologic treatments.

Clinical trials are conducted within an intensely regulated environment to ensure safe and effective treatments are approved for use. The ethical considerations and trial participants’ wellbeing is central to the research process. The conduct of clinical trials is complex and requires staff to be both knowledgeable and multi-skilled to meet the demands of the clinical trial protocol and its requirements.

While the primary aim of conducting clinical trials is to identify new treatments which will improve health outcomes for patients, clinical trials occur within a wide range of clinical contexts, such as improving disease prevention, diagnosis, and the quality of life and psychological wellbeing of patients and their caregivers.

The involvement of nurses and other health professionals in clinical trials practice

Nurses play a central role in patient care as the largest professional group working in health care and are routinely involved in treatment and supportive care decisions to improve patient outcomes. The role of the clinical trials nurse and coordinator has evolved in recent years as integral to the successful conduct of trials. Clinical Trials staff need to be multi-skilled in the management of the clinical trial protocol, as well as other key responsibilities such as managing staff resources and clinical trial data, monitoring and reporting study progress to sponsors, clinical investigators, ethics committees and regulatory agencies.

Postgraduate educational opportunities in clinical trials

With the increasing complexity of clinical research and its regulation, a greater level of knowledge and expertise is required for all staff involved in the clinical trials process.

This new and innovative postgraduate course in Clinical Trials Practice is an excellent opportunity for those aiming to specialise and pursue a career in clinical trials.

Registered nurses from any clinical background or specialty, other health professionals or science graduates with a biomedical/science background are welcome to apply.

Career opportunities available in Clinical Trials Practice

Graduates of this course can expect to pursue careers in roles such as:

  • Clinical Trial Nurse
  • Clinical Trial Coordinator
  • Clinical Research Associate (CRA)
  • Trial Monitor
  • Clinical Research Manager
  • Clinical Research Investigator

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