Study Support Associate

3 days ago


Adelaide, South Australia Avance Clinical Full time

About You

We're looking for a highly organized and detail-oriented individual to join our Clinical Operations Team as a Clinical Trial Associate I (CTA I). As a member of our team, you will be responsible for supporting all aspects of clinical operations from study inception to completion, ensuring compliance with protocols, SOPs, ICH GCP guidelines, and regulatory requirements.

Key Responsibilities

  • Organize, facilitate, and take minutes for project/study team and functional group meetings.

  • Establish, maintain, and track completeness of Trial Master Files.

  • Prepare Investigator Site Files and establish study documentation for assigned studies as required.

  • Liaise with study team members to ensure good communication across each study.

  • Prepare and collect site documentation in conjunction with Project Manager and Clinical Research Associate, from study start up through to end of study.

  • Manage receipt and shipping of study documentation to Investigator sites, maintain internal trackers.

  • Maintain internal databases and assist the Clinical Operations team in ad hoc duties.

  • Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, and respond to audit observations, as required.

  • Ensure Serious Adverse Events are reported (initial and follow-up) as per protocol requirements.

Requirements

  • Bachelor's level degree in life sciences, pharmacy, nursing, or equivalent field (highly regarded), or appropriate industry experience.

  • Previous exposure to a Clinical Trials environment (desirable).

  • Awareness of ICH GCP Guidelines and other applicable regulatory requirements (desirable).

  • Clear understanding of the requirement to adhere strictly to client confidentiality.

  • Effective written and oral communications skills, including the ability to keep clients, senior management, and other stakeholders informed of project updates and other pertinent information.

  • Demonstrated ability to take initiative in problem solving and in exercising good judgment.

  • An understanding of Privacy Legislation as it applies to the Clinical Trial Environment (desirable).



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