Site Navigator II (Study Startup Specialist)

Fortrea; Sydney; On-site; AUD 120,000 - 180,000; Full time

Job summary

Fortrea in Sydney is seeking a Site Navigator II (Study Startup Specialist) to coordinate site start-up activities in line with ICH/GCP, local regulations and project plans. You will be the main contact for investigative sites, guiding feasibility, outreach, site activation and early trial conduct.

The role requires hands-on experience in regulatory submissions, contract and budget negotiations, TMF maintenance, and collaboration with sponsor, CRO and site staff to ensure study milestones are

Qualifications

• University degree in life sciences or allied health certification, or 3+ years clinical research experience.
• Fluent in local language and in English, both written and verbal.
• Strong knowledge of ICH/GCP guidelines and RA, IRB/IEC regulations.
• Experience in start-up regulatory processes and site budgeting/contract negotiation.
• Ability to manage multiple tasks and deadlines.

Responsibilities

• Oversight of site activation tasks per ICH/GCP guidelines, local regulations, SOPs and project requirements.
• Identify potential research sites and assess capabilities and resources.
• Conduct initial site outreach, site engagement, and feasibility surveys.
• Coordinate remote Pre-Study Visits and follow-up documentation for site selection.
• Support translation of informed consent forms and patient materials.
• Collect and review essential documents for site activation; maintain TMF.
• Participate in team meetings and address site-level risks and issues.
• Assist CRA team for SIV preparation and distribution of study materials.
• Liaise with IRB/IEC and regulatory authorities; collaborate with GRSL.
• Negotiate contracts and budgets with sites as applicable.

Skills

Site activation

Regulatory submissions

Contract budget negotiations

IRB/IEC liaison

Study start-up coordination

Cross-functional collaboration

Education

University degree in life sciences

Certification in allied health profession

3+ years clinical research experience

High School Diploma + 5 years clinical research

Job description

Site Navigator II (Study Startup Specialist)

Site Navigator II plays a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical study and potentially through closeout activities as required. Serving as the single point of contact for investigative sites, this role ensures smooth progression from feasibility and initial outreach through to site activation, extending through the maintenance phase of the study as required. A crucial component in meeting the requirements of the Site Navigator II role is ensuring regulatory compliance, robust site management, optimal site support and training, and effective collaboration between the sponsor, CRO, and clinical site staff. This role serves as a local expert in project start-up/clinical activities for a particular country or region, performs work with limited oversight, and acts as a ‘knowledge resource’ to mentor and train junior colleagues if suitable.

Summary of Responsibilities:

Oversight of site level tasks associated with efficient site activation in accordance with ICH/GCP guidelines, local regulations, SOPs and project requirements, including collaboration with project leadership and local monitors to collaboratively achieve project milestones while also ensuring patient rights, wellbeing and safety are protected

Identifying potential research sites that align with the study's criteria and assessing their capabilities and resources.

Conduct initial site outreach, i.e., site engagement, collection of Confidentiality Agreement, and feasibility survey

Remote Pre-Study Visits and follow up documentation, including visit preparation, trip report completion, and other documentation as required to support site selection in line with sponsor, protocol, local and country regulations and requirements

Support customization and translation of informed consent forms and patient-facing materials.

Collect, track and perform a quality review of all essential documents required for effective and compliant study site activation from Site outreach, submissions, greenlight and until site activation. Maintenance and ongoing awareness of site regulatory compliance, supporting IRB/Independent Ethics Committee (IEC) annual renewals, PI change-over, and document expirations will be performed as applicable in accordance with local requirements.

Actively participate in team meetings to facilitate study progress and implement action plans for site level risks, underperforming sites, or issues impacting project milestones and elevate issues in a timely manner

Support the CRA team in preparing for site initiation visits (SIVs) by coordinating with vendors, supplies teams, and study leads to ensure timely distribution of clinical study supplies, accesses and documents per study team guidance.

Responsible for submissions to and liaise with applicable IRB/IEC, Third Bodies (if applicable), and Regulatory Authorities by collaborating with Global Regulatory Submissions Lead(GRSL)

Perform initial contract and budget negotiations with the sites, as well as amended where applicable

Ensure high quality documents are filed in applicable systems in accordance with SOPs and project requirements and that the Trial Master File (TMF) is updated and audit ready at all times.

Track the progress of the start-up process and ensure that the research site meets all requirements and deadlines.

Ensure Fortrea is audit ready by completing accurate, timely, and consistent system compliance on an ongoing basis

Serve as primary contact for investigative sites and ensure timely delivery in alignment with scope of work/study budget

Perform Case Report Form (CRF) review and data validation against source documentation according to protocol and guidelines as applicable in combination with monitoring for site protocol deviations, Serious Adverse Event (SAE) reporting, and all other duties as needed or assigned throughout the course of the study.

Perform country and site ICF review/customization, per local requirements

All other duties as needed or assigned

Qualifications (Minimum Required):

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) or 3+ years' work experience in clinical research, including a strong working knowledge of the ICH/GCP guidelines and RA, IRB/IEC regulations.

Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 5 years' work experience in clinical research, including a strong working knowledge of the ICH/GCP guidelines and RA, IRB/IEC regulations will be considered.

Fluent in local official language and in English, both written and verbal.

Experience (Minimum Required):

A scientific degree and/ or clinical expertise is optimal for this role.

Minimum of 2 +year of experience in clinical start-up/ regulatory process (RGO and Ethics submissions).

Working knowledge of ICH/GCP, RA, TGA, Belberry, and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites.

Demonstrated understanding of research protocol requirements and proven ability to communicate and educate others about them.

Effective communication with various stakeholders, including site staff, CRO personnel, and regulatory authorities.

Ability to manage multiple tasks and deadlines simultaneously, ensuring that all requirements are met in a timely manner.

Understanding of relevant regulations and guidelines related to clinical trials and research.

Ability to identify and resolve potential issues that may arise during the start-up process.

Ability to negotiate contracts and budgets effectively with research sites