The George Institute For Global Health
Global
United Kingdom
India
China
Australia

Senior Clinical Research Associate

Type of career: 
Jobs
Country: 
Australia
City: 
Newtown, Sydney
Application close date: 
05/12/2019

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  • Full time (1 FTE)
  • 2 year fixed term contract
  • Respected global research organisation
  • Make an impact on global health outcomes

‘The George’ is 700+ people focused on improving the health of millions of people worldwide. 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 innovative commercial enterprises help maximise our impact.

Just a sample of the things we’re doing to have the greatest impact on global health:

  • We are identifying better and safer treatments for our biggest killers like stroke, heart disease and high blood pressure
  • In many countries, our award winning FoodSwitch smartphone app is helping people make healthy food choices when shopping
  • We’ve shown that simple text messaging can help prevent heart attack and stroke. Now, we’re working with Google to roll this out globally to prevent chronic diseases affecting millions of people
  • In China, we ran a successful education and awareness program to reduce the amount of salt eaten by people by 25% each day
  • In rural India, we’ve shown that mobile technology can help diagnose mental health, as well as help treat cardiovascular disease, and we’re looking at similar approaches to treating chronic diseases in Indonesia and China
  • Together with Aboriginal communities in NSW, Australia, we’ve developed an innovative community led program to assist young Aboriginal drivers attain their license, now implemented in a dozen of locations
  • We’re developing an affordable dialysis machine, with potential to save millions of lives each year and transform the way kidney disease is treated globally
  • And much more...

An exciting opportunity exists for a Senior Clinical Research Associate (SCRA) to join our growing organisation.

The Senior Clinical Research Associate (SCRA) will support the Project Manager in the development and execution of various research projects (clinical and non-clinical trials) within the academic research programs of work. In addition to site management responsibilities, the SCRA will support the PM on project management-related tasks allocated to them.

Key responsibilities of the role will include:

Clinical Trial Start-up Phase:

  • Participate in the clinical trial feasibility assessment, identify and selects investigators with the PM
  • Site management responsibilities:

    • Prepares and ensure the Human Research Ethics Committee (HREC) submissions are completed within the project timelines
    • Prepares/collects all documents needed prior to study initiation
    • Conducts site initiation meetings to ensure compliance with SOP and all study specific and regulatory requirements are met
    • Develops and maintains a good working relationship with the Investigational site staff
    • Management of the local study files, including in-house and site file
  • Prepares, organises and participates in Investigator meetings

Site management:

  • Conduct on site and remote monitoring of participating centres to ensure:

    • Quality, accuracy, completion, and timeliness of data entry
    • Complete and efficient resolution of data issues and audit findings
    • Adherence to the study protocol and study procedures manual
    • Adherence to ICH/GCP and other regulatory guidelines and requirements as relevant to this trial, including reporting of adverse events/serious adverse events
  • Complete all monitoring visit and progress reports accurately and within study specified timeframe
  • Collect and review essential documents from study sites and ensure they are complete at study close-out and appropriately stored/managed in-house

Overseas regional co-ordinating centre management:

  • Manage and assist regional coordinating staff in the local management of the study where required
  • Conduct co-monitoring with regional coordinating centre staff to ensure adherence to study protocol and study procedures manual
  • Review and sign-off monitoring visit reports

Quality, accuracy and completeness of data:

  • Ensure adherence to regulatory requirements e.g. ICH/GCP, SOPs
  • Assist project team to deliver clean, accurate and verifiable data for final analyses
  • File and archive clinical study data at end of project
  • Ensure patient safety and adverse/serious adverse events are reported according to regulatory requirements
  • Where applicable liaise with staff in Data Management and Statistics Divisions on project specific deliverables

Project Management Delegated Tasks:
The SCRA may be asked to support the PM on project management-related tasks including -

  • Developing tracking, monitoring and filing systems
  • Developing investigator payment tracking system
  • Developing project-specific documents (e.g. Operation manual, monitoring Plans)
  • Ensures appropriate study drug (investigational product) management
  • Manages project related logistics
  • Case Report Form development
  • Data management support of research projects

All activities must be conducted in accordance with project specific documentation, applicable SOPs, ICH GCP (if applicable) and applicable regulatory requirements.

Our ideal candidate will possess:

Essential
  • Tertiary qualifications in a related science or health care discipline
  • At least 2 years of monitoring experience working on clinical projects within an academic, CRO or pharmaceutical environment
  • Working knowledge of, and ability to implement project activities in accordance with, ICH/GCP and all applicable regulations and guidelines in the relevant regions
  • Understanding of medical terminology
  • Excellent knowledge of ICH/ GCP guidelines
  • Understanding of confidentiality and privacy laws and all guidelines relevant to medical research
  • Excellent skills in MS Office applications including Excel and Word
  • Excellent interpersonal skills and the ability to work well and flexibly i.e. autonomously, in small teams and with a wide range of varying stakeholders
  • Strong focus on producing the highest quality of work and on ensuring optimum accuracy of outputs
  • Ability and willingness to travel
We offer a flexible and inclusive work culture with excellent staff benefits including, salary packaging arrangements and sound learning opportunities.
The George Institute is an equal employment opportunity employer committed to equity, diversity and social inclusion. Applications are encouraged from people with a disability; women; Aboriginal and Torres Strait Islander people; people who identify as LGBTIQ; mature-aged adults and those from culturally and linguistically diverse backgrounds.