Study Start-up Associate (Clinical Trial Assistant)

About the role

Primary contact with clinical study sites during study maintenance and site startup activities, with responsibility for collection of required investigator and regulatory essential documents to ensure HREC & RGO submissions are made within agreed timelines.

Key responsibilities

• Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner
• Collect and track all necessary documents and perform quality review, formatting, and compilation of final documents for effective and compliant site activation and maintenance
• Assist senior staff to compile, prepare, submit, and obtain approval of submission documents to Ethics/Regulatory Authority in accordance with local requirements
• Ensure all assigned maintenance and start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines
• Update study documents when there are changes in study personnel or study amendments
• Ensure high quality documents are filed and systems are updated on an ongoing and timely basis
• Update status reports, applicable logs, and tracking systems as applicable for projects
• Adapt Informed Consent Forms and other patient facing material to country specific requirements with guidance from line manager and experienced colleagues
• Liaise with internal and external vendors in the generation of Regulatory Authority submissions
• Escalate study issues appropriately and in a timely fashion

About you

• University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)
• Minimum 1 + years of clinical trial experience, and ability to successfully perform the key responsibilities
• Working knowledge of ICH, HREC, RGO, and other applicable regulations/guidelines
• Demonstrated basic understanding of the clinical trial process