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Clinical Research Associate

Acceler8 Clinical Research - Sydney, NSW

Health, Medical & Pharmaceutical
Source: uWorkin


Title: CRA

Reports to: Group Leader Clinical

An exciting opportunity has arisen for a CRA to join a growing global CRO in the Australia division in 2021. The CRA will have access to excellent management and leadership to guide them through a variety of different studies across a range of therapeutic areas. The sites will be across Australia and this unique opening will provide every opportunity to a high performing CRA to take their career onto the next level.

Main Role:

  • Conducts and documents Pre-Study Visits (PSVs), Study Initiation Visits (SIVs)/Qualification Visits (QVs), Monitoring Visits (MV) and Closedown Visits (CV) as per Acceler8 SOPs
  • To monitor and report on Investigator’s adherence to approved protocol/amendments and on study conduct at each study site
  • To ensure that the Investigator maintains all essential documents and that study related documents, including but not limited to source documents and case report forms, are complete and accurate
  • To assist with feasibility studies
  • Manage timely compilation and submission of Ethics Applications and assist in Regulatory applications where required
  • Conduct telephone calls to investigator sites to evaluate potential patient eligibility and enrolment, and to follow-up on any outstanding issues
  • Assist with investigator meetings through the preparation, assembly and shipment of training materials
  • Co-ordinate the collection of essential documentation in accordance with ICH/GCP
  • Identify, document and report SAEs according to ICH/GCP guidelines and local regulatory requirements, within required timelines and follow-up as required
  • Conduct final IMP reconciliation, and arrange return of unused IMPs to the sponsor
  • Be responsible for monitoring and maintaining IMP accountability at investigator sites
  • Prepare site visit reports and status reports, document site actions in follow up letters/e-mail
  • Take telephone calls from team members, investigators and sponsor. Document and follow-up these calls
  • Assist Project Manager/CRA Manager with establishing and implementing the query resolution process
  • Gain an in-depth understanding of the study protocol, CRF and related procedures
  • Develop good working relationships with investigator site personnel and provide support, training and motivation
  • TMF filing and review, as required
  • Assist with general project administration
  • Be responsible for filing of documentation regarding designated sites
  • Adapt protocols/informed consent forms to country specific requirements
  • Develop/implement project specific monitoring tools and tracking forms under the direction of the Project Manager/CRA Manager

Educational requirements:

  • Degree in Life Sciences
  • At least 2 years’ experience as a CRA, preferably within a CRO environment

Position requirements:

  • Full driving licence with the ability to travel up to 3 days/week
  • Would consider Full Time or Part Time
  • Would consider Home Working

Key skills required:

  • Fluent written and oral English language including familiarity with medical terminology
  • Good oral and written comprehension, professional communication
  • Able to work with minimum supervision
  • Ability to order and prioritise tasks
  • Numeracy
  • Good attention to detail
  • Excellent time management skills
  • Professional/Technical interest
  • Computer Literacy
  • Good Initiative/Self-starter
  • Enthusiasm/motivation

Part-time hours: 37.5 per week

Job Types: Full-time, Part-time, Permanent


  • Referral program
  • Travel reimbursement
  • Work from home


  • Monday to Friday

Supplementary Pay:

  • Performance bonus

COVID-19 considerations:
We have a COVID-19 Policy which all employees globally must adhere to

Work Eligibility:

  • Permitted to work permanently with no restriction on hours (e.g. citizen, permanent resident) (Preferred)

Work Remotely:

  • Yes

COVID-19 Precaution(s):

  • Remote interview process
  • Temperature screenings
  • Virtual meetings

Sydney, NSW

Health, Medical & Pharmaceutical


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