Clinical Site Navigator

Fortrea; São Paulo; Híbrido; BRL 120.000 - 150.000; Tempo integral

Resumo da oferta

A leading clinical research organization is looking for a Clinical Site Navigator to manage site-level activities throughout the start-up of clinical trials. This hybrid role involves ensuring compliance, excellent site management, and collaboration with clinical staff. Candidates must have a scientific degree and two years of experience in the pharmaceutical or CRO industry, particularly in Pharmacovigilance or Safety writing. The position offers a full-time employment opportunity in São Paulo, Brazil.

Qualificações

• Minimum of two years of experience in the pharmaceutical, biotechnology, or CRO industry.
• Experience in Pharmacovigilance or Safety writing.
• Knowledge of Good Clinical Practice (GCP) and regulatory requirements.

Responsabilidades

• Oversight of site level tasks for efficient site activation.
• Identifying research sites meeting study criteria.
• Conducting site outreach and feasibility surveys.
• Performing remote pre-study visits for site selection.
• Tracking start-up process and ensuring compliance.
• Serving as primary contact for investigative sites.

Conhecimentos

Knowledge of medical and drug terminology

Ability to present and share useful business information

Ability to anticipate and identify problems

Technical proficiency with Microsoft Office suite

Formação académica

Scientific degree or clinical expertise

Descrição da oferta de emprego

Job Description

The Clinical Site Navigator role is a hybrid position that combines start‑up and iHCRA / CRA responsibilities. Site Navigators play a critical role in the comprehensive coordination of site‑level activities throughout the start‑up phase of a clinical trial and potentially through closeout activities as required. Serving as the single point of contact for investigative sites this role ensures a smooth progression from feasibility and initial outreach through to site activation extending through the maintenance phase of the trial as required. A crucial component in meeting the requirements of the hybrid start‑up / CRA role is ensuring regulatory compliance, robust site management, optimal site support and training and effective collaboration between the sponsor CRO and clinical site staff. A scientific degree and / or clinical expertise is optimal for this role.

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.
• Conducting initial site outreach i.e. site engagement, collection of Confidentiality Agreement and feasibility survey.
• Performing 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.
• Supporting 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 through greenlight to site activation. Maintenance and ongoing awareness of site regulatory compliance supporting annual renewals, PI changes and document expirations will be performed as applicable.
• Participating in team meetings to progress trials and implement action plans for site level risks, under‑performing sites or issues impacting project milestones.
• Supporting the CRA team in preparing for SIVs by coordinating with vendors, supplies teams and study leads to ensure timely distribution of clinical trial supplies, access and documents per study team guidance.
• Supporting submissions to and liaising with applicable IRB / IEC third bodies (if applicable) and Regulatory Authorities by collaborating with Global Regulatory Submissions Lead (GRSL).
• Performing initial contract and budget negotiations with the sites.
• Ensuring high‑quality documents are filed in applicable systems in accordance with SOPs and project requirements.
• Tracking the progress of the start‑up process and ensuring that the research site meets all requirements and deadlines.
• Ensuring Fortrea is audit‑ready by completing accurate, timely and consistent system compliance on an ongoing basis.
• Serving as primary contact for investigative sites and ensuring timely delivery in alignment with scope of work / study budget.
• Facilitating the preparation of the research site for patient enrollment including staff training, protocol review and equipment setup.
• Performing CRF review and data validation against source documentation according to protocol and guidelines as applicable in combination with monitoring for site protocol deviations, SAE reporting and patient safety concerns escalating as applicable.

Experience (Minimum Required)

Two plus years of overall work experience in the pharmaceutical industry, biotechnology or CRO industry, primarily in Pharmacovigilance / Safety writing with some experience in peer review / quality review.

Ability to present and share useful business information across departments and functions.

Ability to anticipate and identify problems and take appropriate action to correct.

Knowledge

Knowledge of medical and drug terminology.

Knowledge of Good Clinical Practice (GCP) and GVP requirements related to clinical safety and post‑marketing documentation.

Knowledge of ICH Guidelines.

Knowledge of worldwide regulatory requirements and reporting of adverse events for both marketed and investigational products.

Knowledge of regulatory requirements viz. GVP and applicable EU and FDA guidelines.

In‑depth understanding of case processing and assessment.

Technical proficiency with Microsoft Office suite of applications.

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Employment Details

Employment Type: Full‑Time

Experience: years

Vacancy: 1