Country: Australia or New Zealand
Working schedule: Permanent headcount, office based (Australia), remote based (New Zealand)
The Role:
Collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation in accordance with SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines and the principles of ICH/GCP.
What you will be doing:
• To review and negotiate clinical site investigator contracts and budgets.
• Stay connected with Investigative sites, sponsors and internal personnel regarding the status of contracts and contract-related documents
• Prepare and coordinate preparation of contractual documents and correspondence
• Facilitate the indemnification process between the study sponsor and the site.
• Function as the internal consultant on study budgets (investigator payments, develop and update training documentation and conduct group training as necessary, mentor and train new and junior personnel in the SSU department, and act as consultant on the Investigator Contract and Budget development process from origination through execution).
To be successful in the role, you will have:
• A bachelor’s degree in the relevant industry field and related experience is preferred
• Possesses study start up experience in clinical trials
• Experience in a clinical research environment with specific experience in study contracts review and budget negotiation or in related field such as where contract or legal document review is a primary part of your role.
Apply here: https://careers.iconplc.com/job/study-start-up-associate-ii-in-new-zealand-auckland-jid-35424