Clinical Trials Coordinator Site Monitor (Remote)

Clinical Trials Coordinator Site Monitor | ANZUP Cancer Trials Group | Australia

Who we are and why you might love to work with us:

ANZUP is the leading cancer cooperative clinical trials group whose mission is to improve the lives of people affected by bladder, kidney, testicular, penile and prostate cancers through practice-changing multidisciplinary collaborative clinical trials.

You can find out more about us at www.anzup.org.au

We offer a small friendly working environment with a highly skilled team who are passionate about supporting and helping the ANZUP membership achieve ANZUP’s mission. We also offer:

• A competitive remuneration package plus NFP salary packaging
• Permanent Full-time – 35-hour week
• Hybrid working days
• Health & Well-being and Thank You days
• A paid parental leave policy
• Our modern offices are located in at Barangaroo with great views close to Wynard station

The position:

The Trial Coordinator / Site Monitor is a newly created position due to ANZUP’s expanding Clinical Trials Portfolio and Translational Research Program. This role would be well suited to candidates with solid experience in multi-site clinical trials coordination and risk-based site monitoring.

Key responsibilities:

• Ensure that studies coordinated by ANZUP maintain high scientific and ethical standards in accordance with the Protocol, Good Clinical Practice (GCP) and regulatory requirements;
• Facilitate trial site start up activities including site approvals, initiation and activation;
• Manage, monitor, and report on ongoing trial site activity and close out activities as appropriate; 
• Manage trial investigational product supply processes;
• Create and maintain the Trial Master File for sites and perform ongoing quality control activities, including risk-based monitoring activities;
• Oversee and manage, in collaboration with internal and / or external partners the creation and ongoing implementation of the trial database / case report forms;
• Work with the Project Manager to develop and implement study manuals and plans; 
• Manage and run Site Initiation and Close Out Visits, and management of ongoing site staff training as required;
• Oversight and reporting of safety events, and protocol deviations; 
• Liaise regularly with sites to manage essential documents from start-up to close-out;
• Assist Project Manager with central trial committee activities as needed;
• Assist Project Manager with development and management of project and financial tracking tools;
• Regular reporting on the progress of a trial, including reporting on performance of participating sites in respect to recruitment, patient compliance, safety reporting, and data quality;

Skills you will bring to the role:

• Relevant experience in a clinical trials site coordination/ site monitoring;
• Relevant experience working with multidisciplinary medical, health and research teams;
• Deep knowledge of clinical trial processes and the clinical trials regulations;
• Strong communication skills; 
• Relevant proficiency in the use of the Microsoft Office suite of products, including Word, Excel, PowerPoint and Outlook, Office 365, trial databases (EDC) e.g REDCap; 
• Current ICH-GCP certification or willing to undertake as training will be provided
• Ability to work well and flexibly and autonomously as part of a team.

To be considered for this role you need to have completed a Masters degree or an equivalent combination of relevant experience and/or education and training in clinical trials site management and monitoring settings

If this sounds like the role you have been waiting for please submit your resume and cover letter that supports your skills and experience to be successful in this role.

Tagged as: remote, remote job, virtual, Virtual Job, virtual position, Work at Home, work from home