[Hiring] Site Navigator II @Fortrea

Role Description

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.

Qualifications

• 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.

Requirements

• A scientific degree and/or clinical expertise is optimal for this role.
• Minimum of 2+ years of experience in clinical development or start-up/regulatory process.
• Working knowledge of ICH/GCP, RA, IRB/IEC, 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.

Benefits

• Remote-based work required with possible office presence depending on location.
• Travel requirements: Limited for training only.