Clinical Trial Coordinator (Haematology)

Established in 2013, the Perth Blood Institute is one of the largest haematology research centres in Australia. The Perth Blood Institute is a not-for-profit research institute focused on delivering the highest possible standard of care for people diagnosed with blood disorders.

• We are seeking an experienced Clinical Trial Coordinator to join our Clinical Trial unit on a 12-month full-time contract, with permanency review at 6-months of service. 

Benefits

• Generous salary packaging benefits apply
• Flexible work arrangements (family friendly)
• Training and Development opportunities

Key Responsibilities:
As a Clinical Trial Coordinator, you will coordinate industry-sponsored Clinical Trials from start up to close out, including but not limited to: collection of essential documents, patient liaison, preparation of source document templates, patient recruitment, data collection and entry.

You will work closely with investigators, nurses, and other professionals to achieve high-quality research data and promote excellent outcomes for patients enrolled onto Clinical Trials.

Key activities include but are not limited to:

• Coordinating and performing patient assessments (i.e. measuring vitals)
• Recording patient ECGs
• Conducting cannulations on difficult patients to collect blood samples
• Attend investigator meetings (IM) and Site Initiation Visit (SIV) when appropriate
• Assist Start-up and HREC coordinator to prepare and submit Clinical Trial documents for HREC and governance review
• Prepare study materials including, but not limited to, the informed consent (PICF), case report forms (CRFs), Source documents, enrolment logs and drug/device accountability logs
• Establish, organise, and maintain study documents, including but not limited to, regulatory binders, study specific source documentation, trackers, and other materials in adherence with study protocols
• Screen and document subjects’ eligibility using protocol specific inclusion and exclusion criteria
• Coordinate participant screening tests and procedures
• Conduct study assessments and collect data as required by the protocol in line with relevant standard operating procedures and policies
• Ensure timely completion of eCRF and responses to queries
• Maintain study timelines and report protocol deviations
• Complete study documentation and maintain study files in accordance with sponsor requirements and PBI policies and procedures including, but not limited to, consent forms, source documentation and progress notes
• Assist the PI with scientific, safety and compliance reporting requirements in accordance with Sponsor, TGA, NHMRC and HREC policies and procedures
• Assist the PI in submission of accurate annual reports and timely close-out documents to HREC and applicable governing bodies
• Coordinate and facilitate monitoring and auditing visits

Skills/Experience Required:

• Tertiary qualification, preferably in nursing or a health-science related field
• 1 year experience coordinating haematology Clinical Trials or 2-3 years experience coordinating Clinical Trials (i.e., industry-sponsored pharmaceutical trials and well-versed with ICH-GCP and regulatory requirements for conducting Clinical Trials)
• The ability to produce written work of a high standard with attention to details
• High level communication and interpersonal skills with the capacity to work effectively with Sponsors, management, colleagues, clinical and support staff
• Highly developed work organisation skills with the capacity to prioritise competing demands

How to Apply:
Please attach a cover letter addressing the above selection criteria and a CV.
If you have any questions, please email **@pbi.org.au or call 9383 3293.
  
Applicants must have unrestricted Australian working rights.Please note that only shortlisted candidates will be contacted.