The role would be ideal for an individual keen to demonstrate and drive their monitoring and site management skills whilst gaining experience working with industry-leading systems and processes. The successful candidate will play a key role in managing multiple sites in different therapeutic areas, driving site start-up, patient recruitment, risk management and monitoring activities in accordance with ICHGCP guidelines.
Experience & Skills
Key responsibilities include (but not limited to):
- Prepare, organise, conduct and follow-up on routine monitoring and close out visits as per relevant trial plan.
- Motivate and train site staff on all aspects of the trial to ensure obligations with regards to study timelines and deliverables.
- Accountability for patient recruitment strategies, including implementation of mitigation actions.
- Site engagement and customer relationships
- Ethics submissions are made in a timely manner.
- Adherence to ICH-GCP and any other regulatory guidelines and requirements including adverse events and serious adverse event reporting.
- Compliance with mandatory SOPs as agreed for the study.
- Complete all reports accurately and within the predetermined timelines.
- Frequent local and interstate travel.
Qualifications & Requirements
- Tertiary qualifications in a related science or health care discipline.
- At least two years’ experience in clinical trial monitoring within a CRO or pharmaceutical company.
- Excellent working knowledge of ICH-GCP, ethical and regulatory requirements.
- Excellent interpersonal skills, presentation skills and the ability to work well and autonomously, in small teams and with a wide range of varying stakeholders.
- Excellent organisational skills - ability to organise, take initiative and follow-up independently.
- Familiarity with computer systems particularly MS and electronic data capture and CTM systems.
- Focus on detail and quality work.
- Ability and willingness to travel.
- You must either be an Australian Citizen or have a current residency Visa to live and work in Australia.
This is a three-year contract role and comes with an attractive salary package as well as the ability to work predominantly from home or remotely, with attendance in the North Sydney head office as required.
Applications will be processed as they come in so please apply today for this life-changing opportunity!
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