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CRA II / SCRA (Relocation to Australia)

Employer
ICON - Australia
Location
Australia
Salary
Flexible
Start date
9 Nov 2021
Closing date
9 Dec 2021

View more

Discipline
Clinical Research, Clinical Operations, Clinical Research Associate
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

Title: Clinical Research Associate II / Senior Clinical Research Associate

Location: Australia

 

 

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

 

 

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

 

 

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

 

 

In this role, you will be part of our Strategic Solutions Division and be directly partnering with one of our top pharmaceutical sponsors with the support of ICON right behind you.

 

 

Position overview:

 

 

Working fully embedded within one of our pharmaceutical clients, with the support of ICON right behind you, you’ll be at the heart of our client’s innovation.

 

 

As a Clinical Research Associate, you will be dedicated to one of our global pharmaceutical client; with whom ICON 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 Clinical Research Associate is ultimately responsible for the successful management of investigator sites and monitoring activities for assigned clinical studies throughout the trial lifecycle. Key responsibilities include:

 

 

  • Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines
  • Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
  • Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
  • Provides regular site status information to team members, trial management, and updates trial management tools
  • Completes monitoring activity documents as required by PRA SOPs or other contractual obligations
  • Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
  • Escalates site and trial related issues per PRA SOPs, until identified issues are resolved or closed
  • Performs essential document site file reconciliation
  • Performs source document verification and query resolution
  • Assesses IP accountability, dispensation, and compliance at the investigative sites
  • Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines
  • Communicates with investigative sites
  • Updates applicable tracking systems
  • Ensures all required training is completed and documented
  • Serves as observation visit leader
  • Facilitates audit s and audit resolution

 

You are:

 

Passionate, innovative and committed.

 

Here at ICON we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

 

  • Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
  • A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
  • You will be educated to degree level in a life science discipline or be a licensed healthcare professional.
  • Minimum of 2 years relevant CRA experience
  • Have completed English test, Police check for country of residence and police check for other countries if you have lived overseas within the past 10 years at the time of application.

 

 

Benefits of Working in ICON:

 

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

 

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

 

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

 

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Company

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

 

Find Us
Website:
Telephone
02 9289 8500
Location
Central Square
Suite 1701
323 Castlereagh St
Haymarket
N/A
NSW 2000
AU
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