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Clinical Data Coordinator

1 week ago

City of Moreton Bay, Australia UniSC Careers Full time
Job Overview
This is a fantastic opportunity to work with UniSC Clinical Trials in the Health Hub Morayfield. As a Data Compliance Associate, you will be involved in all aspects of Data Management for assigned clinical trials according to client specifications, protocol, project plan, Data Management Plan, relevant GCDMP guidelines, regulatory requirements and SOPs.

Key Responsibilities
You will administer and coordinate all aspects of data management for each assigned clinical trial according to protocol and client expectations and timelines. This includes assisting in the review of eSource in liaison with systems and the clinical team, liaising with the clinical team in coordination of data management across the lifecycle of the clinical trial protocol, conducting internal study eSource and electronic Investigator Site File (eISF) audits at assigned sites, and identifying data non-compliance trends and escalating as appropriate.

About You
We are looking for a highly organized and detail-oriented individual with strong computing skills, including proficiency in electronic data capture platforms. Your excellent written and verbal communication skills will enable you to manage and communicate complex information effectively. A degree qualification in Health Science/Bio-Medicine or related field, experience in a clinical research or data management background, clinical research monitoring experience or exposure, detailed knowledge of International Conference on Harmonisation E6 (R2) Good Clinical Practice (ICH GCP) and national regulations, and exposure to internal/external audits are essential.

What We Offer
As a valued member of our team, you will enjoy a competitive salary package and opportunities for professional growth and development.