PRA - Australia

Lead Clinical Research Associate

Location
Sydney
Salary
Base + car allowance
Posted
23 Apr 2021
Closes
11 May 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Lead Clinical Research Associate

Location: Australia

One thing we all have in common is the drive to produce great results for our clients and to advance treatment options available to patients worldwide. We always have a desire to keep seeking new and better ways to operate, to achieve these results. Enter: the Strategic Solutions Division.

Leveraging the advantages of working for a top-5 CRO, whilst simultaneously working fully-dedicated to a leading biotechnology company, will guarantee that the results you help accomplish in drug development are matched by your own career achievements.

Position overview:

As a Lead CRA, you will be dedicated to one of our global biotechnology clients; a client with which PRA shares a culture of innovation, flexibility and a common vision of bringing life-improving drugs to market. Leading by example, you can set the standard of excellence and enjoy a challenging career in this exclusive program. The Lead CRA is responsible for the country-level management of one or two studies from feasibility to study archive, and for communicating the progress and status of the studies to other key players within the team. Adopting a quality-focus to your work on complex global studies, your main responsibilities will include:

  • Owning the study planning, progress, quality and tracking, at a country level, with full accountability for the local CRA team
  • Collaborating with other global study team members, reporting to them on study progress via monthly reports, or ad hoc as required
  • Tracking study milestones to guarantee overall delivery
  • Preparing the core country documents for successful study initiation, enrolment and maintenance, including the country enrolment plan
  • Designing and delivering training to the CRA team to ensure quality site management and adherence to all applicable regulations
  • Proactively identifying potential issues and implementing risk-mitigation plans to ensure successful study delivery
  • Managing the country study budget
  • Training CRAs on all aspects of the study, performing occasional co-monitoring visits and reviewing trip reports
  • Delivering expert-level site management, taking full ownership of sites, to include all aspects of site management and monitoring
  • Functioning also as a Senior CRA, you will also ensure control of study medication, deliver site-specific training, tracking enrolment at a site level and reviewing essential documents at site

Working consistently and efficiently in this role, no two days are the same as you collaborate with other study team members to bring these life-improving treatments to market.

 

 

 

Qualifications

You are: Quality-focused, detail-orientated and a key contributor to success. To enable success in this position you will have:

  • Prior experience of leading studies at a country-level, as a Study Manager or Lead CRA
  • A proven track record of success in site management and on-site monitorin
  • A working knowledge of ICH-GCP guidelines and local and international regulatory requirements
  • Prior exposure to budgets and feasibility within clinical trials is an advantage
  • Degree educated in a life science discipline or international equivalent
  • A flexible, open-minded and culturally-aware approach to your work

“PRA Health Sciences is an equal opportunities employer; we welcome and celebrate diversity in the work place and we strive to ensure that all employees feel safe, connected and secure in their working environment”