This position is no longer open for applications

Clinical Research Associate

Clinical Research Associate (37065) St Leonards, Sydney, Australia

Clinical Research Associate

 

  • Manage multi-disciplinary clinical trials for a novel medical device
  • Work for a highly innovative medical device company
  • Competitive salary package

 

Benefits

 

  • Close knit and inclusive team
  • Chance to design and implement clinical trial protocols
  • Clear career progression to become a SCRA
  • Flexible work from home arrangement

About the Company

The company is a highly innovative and dynamic, small sized medical device company based in Australia. They pride themselves on a very inclusive working culture, with emphasis on professional development and taking initiative. They have developed and implemented a novel medical device for multi-disciplinary oncology trials across Australia and New Zealand.

About the Opportunity

The CRA will manage study design and implementation of clinical trials including initiating and maintaining sites, overseeing site staff, managing data collection and verification, performing all ethics and governance submissions and ensuring patient safety.

Duties

  • Overseeing clinical trials to ensure obligations and timelines are met
  • Ensure trials are compliant with ICH-GCP guidelines and ISO 14155
  • Instruct site staff from initiation through to site close out on proper clinical trial conduct and procedures
  • Establish clear lines of communication between site staff and team members
  • Manage all data collection, review and query resolution
  • Execute trials following company SOP’s
  • Manage all adverse event reporting and regulatory submissions following applicable local regulations
  • Participate in the ongoing training of all staff members

Skills and Experience

  • Tertiary degree in life sciences M.S.C or Ph.D. preferred
  • Ideally 2-3 years local monitoring experience
  • Ideally have experience in oncology trials preferably in a CRO or a Sponsor
  • Medical device experience preferred but not essential
  • Must have excellent communication skills
  • Excellent knowledge of ICH-GCP guidelines
  • Willingness to travel as required

Culture

 

Company prides itself on having a supportive team and has a very low turnover.  A can-do attitude is highly rewarded and work governance is encouraged.

 

 

How to Apply

 

Click apply or for a confidential discussion contact:

Davina Ocansey, Recruitment Consultant on +61 2 8877 8712; or

Mattias Fitzgerald, Resourcing Consultant on +61 2 8877 8749

 

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