Senior Site Start-Up Associate II - Remote AU

Premier Research Group; Australia; Remote; AUD 90,000 - 130,000; Full time

Job summary

Premier Research is seeking a Sr/Site Start up Associate II to join our Clinical Monitoring, Site Management and SSU team in a remote role covering regional Australia. You will drive country-level start-up activities, prepare regulatory submissions and liaise with sponsors and sites to keep timelines on track.

Your background includes 2+ years in SSUA roles, familiarity with ICH/GCP, and the ability to negotiate contracts and budgets while ensuring compliance with local rules.

Qualifications

• Bachelor-level qualification in a clinical, science or health field is required.
• Experience with site start-up and regulatory submissions is essential.
• Solid knowledge of ICH/GCP guidelines and relevant country rules.

Responsibilities

• Takes responsibility for quality deliverables at country level for study start-up and ensures timelines are met.
• Prepares and submits EC/IRB, RA and local regulatory submissions as required.
• Negotiates site contracts and budgets with sites and sponsors.
• Maintains country regulatory intelligence in central repositories.
• Serves as liaison for site start-up issues and coordinates with PM, CL and RA teams.
• Resolves regulatory issues and escalates delays with clear contingency plans.

Skills

Site start-up

Regulatory submissions

ICH/GCP

FDA/EU regulations

Contract negotiation

Pediatric/Neuroscience studies

Education

Undergraduate degree in clinical/health field

Licensed healthcare professional

Job description

Premier Research is seeking a Sr/Site Start up Associate II to join our Clinical Monitoring, Site Management and SSU team in a remote role covering regional Australia. You will drive country-level start-up activities, prepare regulatory submissions and liaise with sponsors and sites to keep timelines on track.

Your background includes 2+ years in SSUA roles, familiarity with ICH/GCP, and the ability to negotiate contracts and budgets while ensuring compliance with local rules.