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In House Clinical Research Associate - Australia

Employer
Worldwide Clinical Trials - APAC
Location
Australia;Homeworking
Salary
Competitive
Start date
8 Dec 2021
Closing date
7 Jan 2022

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Job Details

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates, and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

What Clinical Operations Site Management does at Worldwide

Clinical Trial Managers (CTMs) and Clinical Research Associates (CRAs) play a vital role in ensuring our clinical research programs are executed with the quality and excellence our sponsors expect and the care and passion patients deserve.

These roles are the backbone of every strong CRO, helping drive breakthrough scientific research and playing a lead role on every clinical trial. All CROs will promise you growth, opportunity and maybe even a challenge. But we offer more than that. We offer an uncommon experience - one you can’t get anywhere else, with a team unlike anyone else.

At Worldwide we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every trial like a patient’s life depends on it - because it does. Our leaders are in the trenches with you daily - committed to advancing science and moving mountains for our customers.

What you will do
  • Responsible for performing feasibility studies/site identification activities and coordinating study material shipments.
  • Ensure completeness and compile regulatory documents and ethical submission documentation as appropriate and required (e.g., IRB approval, informed consent, lab certification etc.).
  • Maintain Investigator Site File in the TMF and provide applicable updates for site related study documentation.
  • Conduct pre-study, study initiation, interim monitoring visits under the guidance of the local CRA or CTM/PM, as applicable and appropriate. Document findings from site visits.
  • Complete remote CRF review, using electronic data capture systems and assist sites in query resolution.
  • Maintain study trackers, generate reports and be the point-of-contact for the sites.

What you will bring to the role
  • Excellent interpersonal, oral, and written communication skills in English
  • Superior organizational skills with attention to details
  • Ability to work with little or no supervision
  • Proficiency in Microsoft Office, TMF, CTMS and EDC Systems


Your experience
  • Requires a bachelor’s degree or a two-year nursing degree require
  • Minimum of two years of clinical in-house or regional CRA experience

Why Worldwide

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it - because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.

#LI-MM2
#LI-Remote

Company

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 2,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Company info
Location
Suite 70
Shinagawa Intercity Tower A
Level 28 2-15-1 Konan
Minato--ku
Tokyo
108-6028
Japan

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