The HRB-Clinical Research Facility provides dedicated specialist research nursing with the skills and experience for research study needs with a focus on the care of research participantsThey have a comprehensive understanding of the specialty in which they work and also an extensive knowledge of the research process and research-related legislationThe HRB-CRFG nurses are at the forefront of new developments in the treatment of patients and play a key role as patient advocate, ensuring patients' safety and protection, and that patients are well supported throughout the research study process.

Our research nurses work in conjunction with Principal Investigators (PIs) and multidisciplinary study teams to:

  • Ensure all studies are opened and conducted to the highest standards in accordance with ICH-GCP guidelines, study protocol and applicable regulations. 

  • Ensure that participants are fully informed of all details pertaining to the clinical trial/research project and fully comprehend study involvement prior to providing voluntary consent to participate.  

  • Assess potential study participants for study eligibility and coordinate relevant procedures for clinical research participation. 

  • Participate in the education process of study participants about their disease, research participation requirements, gold standard treatment options and outcomes  

  • Develop and implement recruitment strategies to increase patient recruitment within research studies. 

  • Carry our randomisation procedures per study protocol 

  • Ensure accuracy and quality of data collection and prompt transfer to eCRFs along with timely query resolution 

  • Maintain and manage research documentation in accordance with Standard Operating Procedures (SOPs) 

  • Prompt reporting of adverse events in line with the study protocol and GCP which is fundamental to patient protection. 

  • Provide phlebotomy, bio specimen sample handling and processing, storage and dispatch to campus-wide and external laboratories as required.  

  • Supporting the Principal Investigator (PI) by coordinating the day to day management of research studies 

  • Ensure continuity of patient care by liaising with outside health professionals and those who are involved with patient’s clinical care. 

  • Providing on-going support to patients throughout their time as a participant 

  • Act as teachers, mentors and advisors to other health professionals within a multidisciplinary team 

  • Prepare research studies for Internal / Sponsor / Regulatory audits as required 

  • Collaborate and liaise effectively with Sponsors, affiliated research staff and external vendors.

The HRB CRFG Clinical Trial Assistant (CTA) plays a crucial role by assisting the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing administration and project tracking support. The Research Assistant is responsible for undertaking and assisting with the daily conduct of allocated studies, performing study tasks as appropriate, scheduling activities, and reporting along with the collation and management of data and the delivery of a pre-defined set of outcomes, as set out in each study protocol.

The Clinical Research Associate/Assistants:

  • Collaborate with PIs and the study team personnel to assist in the conduct and coordination of studies 

  • Assist in the recruitment and enrolment of study participants 

  • Perform study scheduling 

  • Track patient participation 

  • Prepare and administer patient related study documents and material 

  • Prepare tissues, cell cultures, blood samples etc. for testing 

  • Develop research survey, questionnaire, and/or tests 

  • Develop and maintain research databases