Summary
Overview
Work History
Education
Skills
Timeline
Generic

Brenda Trezona

Adelaide,SA

Summary

Proven Clinical Research Coordinator at Lyell McEwin Hospital, adept in Good Clinical Practices and fostering teamwork.

Areas of Clinical Trial Experience

Phase 2 & 3 / Pharmaceutical and Investigator Lead Studies.

  • Endocrine - Diabetes Type 1 and 2
  • Renal CKD
  • Hepatology NASH / MASH
  • Cardiology Stemi / Non Stemi , AF , Devices, ACS.
  • Gastrology - Crohn's, Ulcerated Colitis, Eosinophilic Oesophagitis
  • Neurology - Stroke
  • DVT / PE
  • Hypertension
  • Metabolic
  • Congenital Adrenal Hyperplasia
  • Sleep Study

Overview

34
34
years of professional experience

Work History

Clinical Research Coordinator

Lyell McEwin Hospital
04.2006 - Current
  • Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
  • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
  • Gathered, processed, and shipped lab specimens.
  • Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
  • Attended investigator meetings and executed research activities from study start-up to close-out as per protocol requirements.

• Submission of ethics application, progress reports and safety reports in timely manner.

• Preparation of study materials such as consent forms and case report forms.

• Screening for potential research subjects.

• Documentation of research data in paper or electronic format according to study schedule.

• Management of source documents and site files.

• Liaison with all stakeholders such as doctors, laboratory staff, sponsors, etc.

  • Followed informed consent processes and maintained records.
  • Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
  • Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
  • Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Developed and maintained accurate and up-to-date case report forms and source documents.
  • Monitored patient safety throughout clinical trials and reported any adverse events.
  • Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
  • Managed patient recruitment, informed consent process and data entry to support trial objectives.

Nurse

Lyell McEwin Hospital
12.1999 - 04.2006
  • Casual Nursing Position
  • Worked in various areas of the Hospital.
  • Medical, Surgical, Pediatrics, Cardiac , Women’s Health, Accident & Emergency, Outpatients Department,
  • Gastrology Dept. Same Day Unit, Theatre.

Nurse

Nursing Agency Of South Australia
01.2000 - 12.2000

-Worked in a variety of places in Adelaide.

Private & Public Hospitals - In areas of Medical, Surgical, Same Day Units.

-Aged Care Nursing Homes.


Nurse

Australian Red Cross Blood Bank
12.1990 - 08.1998

Consults Donors

Medical reviews, eligibility to donate.

Haemoglobin checks

Phlebotomy and collection of blood, plasma donations.

Accurate documentation

Entering data

Sending blood, plasma donations to the lab for processing.

Education

Nursing - Nursing Diploma ( END )

Adelaide
Adelaide, SA
01.1997

Skills

  • Good Clinical Practices
  • Electronic Data Capture
  • Documentation Management
  • Adverse event reporting
  • Medical terminology

Teamwork

Multi-tasking Skills,

Study Medication ordered & Collected from Pharmacy, given to patient with PI overview and patient education

Biopsy Collection during procedures of Colonoscopies and Endoscopies

Documentation Requirements

Case Report Management

Planning and Organizational Skills

Customer Service

Flexible Schedule

Team Building / People Skills

Phlebotomy / Processing samples using centrifuge and shipping to required laboratories

Patient Cannulation

Supervision & Leadership

PPE Use

Perform Patient ECG's - Principal Investigator to review

Good Work Ethic

Assist with HREC & RGO submissions, for new and current studies

Maintaining and ordering stock for the Unit

Involved in study start up meetings, Site initiation meetings

Clinical Trial Unit Meetings

Monthly Steering Committee Meetings

Staff Interviews

Primary Study Coordinator, and Back-Up Coordinator for many Studies

Experience in many different types of Clinical Trials

Performance Review and Documentation (PRD 6 Monthly)

SOP writing & reviewing

Experienced with EMR ( Sunrise )

Liaising with Sponsors and Clinical Research Associates

( CRA’s / Monitors )

Timeline

Clinical Research Coordinator

Lyell McEwin Hospital
04.2006 - Current

Nurse

Nursing Agency Of South Australia
01.2000 - 12.2000

Nurse

Lyell McEwin Hospital
12.1999 - 04.2006

Nurse

Australian Red Cross Blood Bank
12.1990 - 08.1998

Nursing - Nursing Diploma ( END )

Adelaide
Brenda Trezona