Site Navigator II – Study Startup Specialist

This is a fully remote position, open to applicants in Australia.

📋 Description

• Supervision of site-level activities related to the efficient activation of sites, adhering to ICH/GCP guidelines, local regulations, SOPs, and project specifications.

• Identifying suitable research sites that meet the study's criteria and evaluating their capabilities and resources.

• Conduct initial outreach to sites, including engagement, collection of Confidentiality Agreements, and feasibility surveys.

• Execute Remote Pre-Study Visits and prepare follow-up documentation, such as visit preparation, completion of trip reports, and any other necessary records.

• Assist in the customization and translation of informed consent forms and materials intended for patients.

• Gather, monitor, and conduct quality reviews of all essential documents necessary for compliant and effective activation of study sites.

• Maintain ongoing awareness of site regulatory compliance, aiding in IRB/Independent Ethics Committee (IEC) annual renewals, Principal Investigator (PI) changes, and document expiration management.

• Actively engage in team meetings to promote study progress and implement strategies for addressing site-level risks, underperforming sites, or issues that may affect project milestones.

• Provide support to the Clinical Research Associate (CRA) team in preparation for site initiation visits (SIVs).

• Responsible for submissions and communication with relevant IRB/IEC, third parties, and regulatory authorities.

• Conduct initial negotiations regarding contracts and budgets with research sites.

• Ensure high-quality documents are stored in relevant systems in accordance with SOPs and project requirements, and that the Trial Master File (TMF) is consistently updated and audit-ready.

• Monitor the start-up process, ensuring that the research site fulfills all requirements and meets deadlines.

• Carry out Case Report Form (CRF) reviews and validate data against source documentation following protocols and guidelines, in conjunction with monitoring for site protocol deviations.

⛳️ Requirements

• A University/College degree (preferably in life sciences) or certification in a related allied health profession from an accredited institution (e.g., nursing certification, medical or laboratory technology), or at least 3 years of experience in clinical research.

• Strong understanding of ICH/GCP guidelines and RA, IRB/IEC regulations.

• Alternatively, candidates with a High School Diploma or equivalent and a minimum of 5 years of experience in clinical research will be considered.

• Proficiency in the local official language and English, both written and verbal.

• Advanced experience in the start-up/regulatory process (TGA and Bellberry).

• Extensive knowledge of HREC & RGO submissions, ICH/GCP, RA, IRB/IEC, and other relevant regulations/guidelines.

• Familiarity with investigator start-up documents and the contract/budget negotiation process.

• Previous experience interacting with operational project teams and investigative sites.

• Ability to handle multiple tasks and deadlines simultaneously, ensuring all requirements are met on time.

• Proficient in negotiating contracts and budgets with research sites effectively.

🏝️ Benefits

• Remote-based work is required, with potential office presence depending on the location.

• Limited travel for training purposes only.