SCRA / Start up Specialist - FSP: Melbourne, Adelaide, Sydney, or Brisbane

About The Role

This unique hybrid role blends the responsibilities of site start‑up, site navigation, and clinical monitoring. As a SCRA / Site Navigator II, you will serve as a trusted partner to investigative sites across the full study lifecycle—from feasibility and activation through monitoring and close‑out. You will play a critical role in ensuring regulatory compliance, patient safety, data integrity, and high‑quality delivery across clinical trials.

Key Responsibilities

• Act as the primary point of contact for investigative sites across start‑up, activation, and monitoring phases
• Coordinate site‑level activities from feasibility and outreach through site activation and ongoing maintenance
• Conduct remote and on‑site monitoring visits, including routine, initiation, and close‑out visits
• Ensure compliance with ICH/GCP, local regulations, SOPs, and protocol requirements
• Manage regulatory submissions, IRB/IEC interactions, essential documents, and TMF quality
• Verify informed consent processes and ensure patient rights, safety, and wellbeing are protected
• Perform source data review, CRF review, query resolution, and data validation
• Track site performance, risks, and timelines, escalating issues proactively
• Support contract and budget negotiations with investigative sites
• Collaborate closely with CRAs, project managers, sponsors, vendors, and internal stakeholders
• Maintain audit‑ready sites and documentation at all times

Experience & Qualifications

• Degree in life sciences or a related field, or equivalent clinical research experience
• 5+ years of experience across clinical research start‑up, site management, and/or clinical monitoring
• Strong working knowledge of ICH/GCP, regulatory requirements, and clinical trial processes
• Experience working directly with investigative sites and cross‑functional project teams
• Excellent organizational, communication, and stakeholder management skills
• Confidence managing multiple priorities in a fast‑paced, matrixed environment
• Willingness to travel as required for monitoring and training activities

Learn more about our EEO & Accommodations request here.