Clinical Trials Study Coordinator

3 weeks ago

Melbourne, Victoria, Australia Sinclair Dermatology Full time

Introduction:

About us:

Sinclair Dermatology is a globally recognised medical centre headed by internationally renowned Dermatologist, Professor Rodney Sinclair. We see over 10,000 patients a year and house Australia's largest Dermatology research and clinical trials centre (Sinclair DIRECT). Our main office is conveniently located in East Melbourne with another two sites in Parkville and Pascoe Vale South.

We have an exciting opportunity for a Full-time Clinical Trials Coordinator.

Description:

Position Description

With team fit a priority, we are seeking an experienced and motivated Clinical Trials Coordinator to join our team. Your supportive and empathetic approach along with your ability to listen to patients will be critical to your success in this role.

Reporting to the Unit Head, the Clinical Trials Coordinator will support investigators to run clinical trials according to the research protocol, ICH-GCP Guidelines, applicable regulatory and local requirements. This role will ensure the day-to-day running of delegated clinical trials in a manner that supports investigators, clinicians, patients and their team.

The role

You will be responsible for but not limited to the following duties:

  • Attend Site Initiation Visits (remote and on-site) for delegated trials
  • Prepare for and host site initiation, monitoring and close out visits
  • Prepare and conduct participant visits
  • Co-ordinate all aspects of allocated clinical trials
  • Complete associated documentation, maintain study binders and other relevant documentation
  • Maintain investigational product and perform accountability
  • Maintain open and regular communication with Sponsors, CRAs and monitors
  • Complete all study close out activities including archiving of all study records
  • Work with the recruitment team to ensure recruitment targets and timelines are met
  • Ensure studies are performed in accordance with GCP guidelines, NHMRC standards, the Australian Safety and Quality Framework for Health Care, relevant Australian laws and regulations, site Standard Operating Procedures (SOPs) and study protocols.

Selection Criteria

Essential
  • Appropriate tertiary qualifications (eg. Science, Pharmacy or related disciplines) will be considered
  • Experience working as a Clinical Trials Co-ordinator is desirable
  • Sound understanding of clinical trials and good understanding of clinical trial phases
  • Sound understanding of the National Statement on Conduct of human research, OHMR policies and guidelines, Privacy and Good Clinical Practice relating to the ethical conduct of human research
  • High level of attention to detail
  • Be committed to the smooth running of clinical trials within your portfolio
  • Ability to handle multiple tasks and prioritise effectively
  • Ability to work efficiently and effectively
  • Familiarity with office-based computer packages, such as Microsoft Word, Excel, Outlook and other relevant software.
  • Demonstrate excellent time management skills
  • Team player
  • Demonstrated high-level oral and written communication skills.
  • Has an empathetic and supportive approach

Additional Benefits
  • Supportive team environment
  • Flexible working hours
  • Immediate start
  • Rewarding industry
  • Staff discounts
  • Conveniently located office within 2 train stations, buses, and trams
  • EAP

Previous applicants do not need to reapply.

Open to Australian Residents Only. Shortlisted candidates will only be contacted.
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