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