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Job Overview:
Site Navigators 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 escalate 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.
Employees will leverage their existing experience and skills to assume additional responsibilities within the broader role. These will be aligned with operational requirements and internal training, without altering the fundamental nature or classification of the position.
Physical Demands / Work Environment:
Remote-based work required with possible office presence depending on location
Travel requirements: Limited for training only
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