[Hiring] Site Navigator I @Fortrea

Role Description

Site Navigators play 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.

• Oversight of site level tasks associated with efficient site activation in accordance with ICH/GCP guidelines, local regulations, SOPs and project requirements.
• Identifying potential research sites that align with the study's criteria and assessing their capabilities and resources.
• Conduct initial site outreach, including site engagement, collection of Confidentiality Agreement, and collection of feasibility survey.
• Apply independent judgment and discretion in managing site-level activities, resolving issues, and making decisions that support study timelines and compliance requirements.
• Remote Pre-Study Visits and follow-up documentation, including visit preparation, trip report completion, and other documentation as required.
• 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.
• Actively participate in study team meetings to support study progress and develop action plans for site-level risks.
• Support the CRA team in preparing for site initiation visits (SIVs) by coordinating with vendors, supplies teams, and study leads.
• Responsible for submissions to and liaise with applicable IRB/IEC, Third Bodies, and Regulatory Authorities.
• Perform initial contract and budget negotiations with the sites.
• Ensure high quality documents are filed in applicable systems in accordance with SOPs and project requirements.
• 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.
• 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.
• Perform country and site ICF review/customization, per local requirements.
• All other duties as needed or assigned.

Qualifications

• University/College degree (life science preferred), or certification in a related allied health profession.
• 2-3 years' work experience in clinical research, including a working knowledge of the ICH/GCP guidelines and RA, IRB/IEC regulations.
• High School Diploma or equivalent AND a minimum of 5 years' work experience in clinical research 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.
• At least one year of experience in a related field (e.g., medical, clinical, pharmaceutical, laboratory research, data analysis, data management or technical writing).
• Basic knowledge of ICH/GCP, RA, IRB/IEC, and other applicable regulations/guidelines.
• Demonstrated understanding of research protocol requirements.
• Effective communication with various stakeholders, including site staff, CRO personnel, and regulatory authorities.
• Ability to manage multiple tasks and deadlines simultaneously.
• 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.

Benefits

• Target Pay Range: $58,000-63,000K USD.

Physical Demands / Work Environment

• Remote-based work required with possible office presence depending on location.
• Travel requirements: Limited to training only.
• Work is performed in an office environment with exposure to electrical office equipment.
• Frequent travel to clients/site locations with occasional domestic and international travel.
• Ability to sit for extended periods and operate a vehicle safely.
• Repetitive hand movement of both hands.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software.
• Light to moderate lifting and carrying (maximum lift of 15-20 lbs).
• Regular and consistent attendance.
• Varied hours may be required.