Clinical Research Associate

Summary about this job

Detail information about job Clinical Research Associate. Terms and conditions vacancy

• Great, collaborative work environment
• Truly improve cancer treatment (non- for- profit organisation)
• Excellent employee benefits (additional leave, flexible times ...)

Great opportunity for home based CRA in Melbourne working on innovative oncology trials across various Phases

Your new company
This Australian- based, non- for- profit research organisation is committed to improve patients treatments suffering from cancer. They provide high quality research and contribute to save the live of millions of patients.


Your new role
In this role you will be responsible for conducting the activities of assigned national and international clinical trials including monitoring and data management. The activities/requirements are determined by the size, type and protocol.

• Ensure trial activities are conducted in compliance with study protocol, ICH GCP, SOP’s and other regulatory requirements.
• Manage the progress of assigned trials proactively by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution with site staff. Manage all adverse events (AE’s and SAE’s).
• Administer protocol to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations, enquiries and issues.
• Enter and maintain data for specific clinical trial/s in the Trial Management Database. Ensure that trial data is of very high quality, check for adherence to protocols, consistency, accuracy and completeness.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
• Perform site initiation, monitoring and close-out visits in accordance with monitoring plan, contracted scope of work and good clinical practice.
• Manage trial medication supply in liaison with hospital pharmacies and suppliers. Manage pathology collection and shipping as required.
• Preparation of trial reports as required.
• Ensure confidentiality of patient databases and clinical trials information.
• Support in continuous improvement of processes.

What you'll need to succeed

• Degree in a relevant subject (like Life Sciences, Health, Nursing or Research).
• At least 1-2 years of proven experience in independent multi-site clinical monitoring in Australia.
• Experience in oncology is essential.
• Attention to detail, ability to respond to changing circumstances.
• Excellent planning and communication skills.
• Self- driven and motivated team player
• Willingness to travel within Australia
• Full working rights in Australia

What you'll get in return
You will be part of a world- leading, well-established research organisation with a supportive company culture and a very passionate team. This role actively helps to improve patients lives. The organisation also offers a very attractive benefits package, that includes flexible working hours, additional leave, personal insurances and a competitive salary package scheme.

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call Krisztina Auth now on +61 (3) 9946 3577.

If this job isn't quite right for you but you are looking for a new position, please contact me for a confidential discussion on your career.