Senior Clinical Research Associate

  • Datapharm Australia is a leading local contract research organisation (CRO) providing clinical trial management monitoring, data management, statistics and reporting for local and global pharma and  biotech companies
  • We are looking for a Senior CRA who wants to take on a lead role in monitoring some of our clinical studies

Senior CRA Role:

As a Senior CRA you will take part in:

  • Develop monitoring plan and train in specific protocol and documents
  • Conduct feasibility for site selection
  • Perform pre-study visits and collect site documents
  • Negotiate site budgets and approval of CTRA
  • Assist prepare HREC submissions
  • Assist in writing or reviewing PICF
  • Set up TMF and ISF – and eTMF
  • Conduct initiation visits (SIVs), interim monitoring visits (IMVs) and Close-out visits (COVs)
  • Conduct remote monitoring visits on ECRFs
  • Write monitoring reports
  • Manage CRO study budget
  • Support our junior CRAs as co-monitor and mentor
  • There will be opportunities to manage projects and assist in proposals
  • Stay actively informed on regulatory requirements

Requirements: Essential:

  • Graduate or Postgraduate with a Pharmacology/ Life Sciences/ Health/ or Nursing background
  • A minimum of 2 years’ experience as a SCRA monitoring trials or over 5 years as a CRA where you are ready to step up to  SCRA level
  • Evidence of training in, and thorough practical knowledge of ICH GCP guidelines and other regulatory requirements
  • Professional manner and excellent communication skills in dealing with sponsors and sites
  • Ability to lead others in your team and manage a project taking on responsibilities
  • Able to travel interstate with overnight stays for monitoring visits

Desirable:

  • Have a passion for science and clinical research
  • Excellent English written and verbal skills
  • Good time management and organisational skills and ability to meet deadlines
  • Eye for detail and accuracy and emphasis on the importance of quality
  • Ability to present at client meetings and to provide training to the team
  • Enthusiasm and willingness to be a flexible part of a busy, interactive and interdependent team

Company:  

Datapharm Australia Pty Ltd is a contract research organisation (CRO) (www.datapharmaustralia.com ). Datapharm provides support to pharmaceutical and biotechnology companies in clinical research by setting up and monitoring clinical trials, collecting and analysing the data from these studies. Datapharm, established in 1987, has a strong position in the industry. Its statisticians provide study design, statistical analysis and reports for many clinical studies each year. A strong reputation for quality and excellence in these areas is resulting in our workload growing.

Other: You must have the right to live and work in Australia to apply for this job. This position is full-time or part-time in-house with a requirement to travel. Datapharm Australia is Sydney based at Drummoyne offices – We are a family friendly workplace. Datapharm reserves the right not to proceed with any appointment.

Salary:

Salary will be negotiated according to experience and qualifications.

Contact:

Please log onto our website to apply and send your application, CV, copies of your university transcripts and at least two referees by clicking on this link: https://datapharmaustralia.com/careers/. Your details will be kept confidential within our company.

Datapharm Australia: 56/56A Thompson St, Drummoyne, 2047, NSW – Phone : 02 9719 2800