The George is 600+ people globally focused on improving the health of millions of people. A medical research institute affiliated with leading universities and with projects in approximately 50 countries, we are challenging the status quo in healthcare to find the best ways to prevent and treat chronic disease and injury, and to influence policy and practice worldwide.
Our Critical Care and Trauma (CC&T) Division has established an international track record in programs of Critical Care research including high-quality, large-scale, randomized controlled trials, cohort and observational studies. To help support these studies we are looking for a proactive Clinical Research Associate (CRA).
The CRA will be part of several study teams assisting with execution and completion of multiple CC&T trials currently running in the CC&T Division.
This is a full time role however we would be willing to consider part time for the right candidate. The position is fixed term for 12 months.
Prepare for, plan, organise and conduct site initiation visits and investigator meetings with/for the Project Manager
Prepare ethics committee submissions
Motivate and train investigators and ensure that the study site personnel have a good understanding of the protocol, the investigational product and the requirements of the study and that they can fulfill their obligations to conduct the study accurately and to deadlines
Site management responsibilities, including but not limited to:
Monitor trial progress at the site and implement strategies as required to ensure adherence to the study protocol, study procedure manual, SOPs, ICH/GCP and other applicable regulatory and ethical guidelines
Assist participating site personnel in the local management of the study where required
Ensure adverse events, serious adverse events and medical events of interest are appropriately documented and reported according to the study protocol and applicable regulatory and ethical requirements
Organise and manage the trial files, including in-house and site trial files, to ensure they are appropriately filed, managed and stored
Detect and report protocol deviations and implement corrective measures as required
Complete all monitoring visit and progress reports accurately and within the predetermined timeframe
Regularly update project tracking tools and systems
Coordinate, track and process invoices for study payments to investigational sites and vendors, accurately and in a timely manner
Manage effective communication with internal and external project staff and key stakeholders (Investigators, Committee members and Research Coordinators, etc)
KEY SKILLS & QUALIFICATIONS:
Tertiary qualifications in a related science or health care discipline with experience within an ICU environment
At least 1 year clinical research experience (particularly within ICU research setting)
Combined experience from industry and academic organisations highly desirable
Excellent working knowledge of ICH/GCP and ethical and regulatory requirements
Understanding of medical terminology and physiology
Excellent interpersonal skills, presentation skills and the ability to work well and flexibly ie autonomously, in small teams and with a wide range of varying stakeholders
Excellent organisational skills - ability to organise, take initiative and follow up independently
Strong computer skills particularly with MS Word, PowerPoint & Excel
Ability and willingness to travel if required (potentially up to 50%), hold a current NSW driving licence and be on 24 hour call
Ability to see the big picture, yet still focus on detail and quality of work