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Clinical Research Associate II

About the Company 
Our client is amongst the largest Clinical Research Organisation (CRO) in the world and provide a wide range of clinical research services to pharmaceutical, medical device and biotech companies.
Our client is an end-to end full service CRO focusing on drug development in early phase (I, Ib) and II-IV phase trials across various therapeutic areas: hematology, oncology and chronic conditions along with innovative areas of research such as immuno-oncology, cell and gene therapy, biomarkers and rare diseases. 

The company has adopted a decentralised clinical trials program that allows for trails to be conducted on various clinical sites across Australia as well as having digital and remote capability.  

The Australian division is growing rapidly and has an immediate need for two Clinical Research Associate II.

About the Role
You will be required to conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. The role is fully remote, based in Perth or greater Western Australia and will require 70 to 80% independent travel within WA and SA.  
Your duties and responsibilities will include:  
  • Initiate clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations.
  • Monitoring investigator sites and manage complex studies.
  • Ensure data accuracy through SDR, SDV and CRF review.
  • Provide update on potential trends across multiple sites.
  • Ensure study systems are updated per agreed study conventions
  • Ensure that required crucial documents are complete in according to ICH-GCP regulations.
  • Performs trial close out and retrieval of trial materials. Conduct on-site file reviews.
  • You will have the opportunity to work across a variety of therapeutic areas. 
NOTE: there are also an option for this role to be based in Brisbane. 

About You
To be considered for this role you must have the following: 
  • Bachelor's degree in medical science or related field or a registered nurse or equivalent
  • Must be an Australian Citizen or Permanent Resident. New Zealand Citizen wishing to relocate to Australia are encouraged to apply. 
  • Previous experience that provides the knowledge, skills, and abilities to perform the job
  • Valid driver's license and the ability to travel.
  • At least 3 years proven clinical monitoring skills
  • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology. Previous experience in vaccines and oncology will be highly regarded.
  • Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
  • Well-developed critical thinking skills for appropriate root cause analysis and problem solving
  • Good oral and written communication skills, with the ability to communicate effectively with medical personnel
  • Good organisational and time management skills
Our client is offering an attractive salary package, car allowance, fuel paid and an annual incentive bonus.  Other company benefits include: paid parental leave, novated lease options, Employee Assistance Program (EAP), paid birthday leave, corporate discounts on health insurance and travel.   
Our client has won many international awards and earned recognition for its global employee learning and development programs and have a strong focus on internal career progression with global mobility opportunities.
Contact Details
If you are interested in this position, please apply online.

For more information about the role, contact Rebecca at KE Select, rebecca@keselect.com or call 0403 644 299 for a confidential discussion.

KE Select are a leading provider of Scientific, Medical and Technical recruitment services. With a candidate and client network spanning ANZ and more recently into APAC, KE Select are no.1 choice for many professionals operating within the Biotechnology and Medical Technology market.
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