Clinical Site Navigator

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:

1. 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

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

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

4. 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

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

6. 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 annual renewals, PI changes, and document expirations will be performed as applicable.

7. Participate in team meetings to progress trials and implement action plans for site level risks, underperforming sites, or issues impacting project milestones

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

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

10. Perform initial contract and budget negotiations with the sites

11. Ensure high quality documents are filed in applicable systems in accordance with SOPs and project requirements

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

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

14. Serve as primary contact for investigative sites and ensure timely delivery in alignment with scope of work/study budget 15. Facilitate the preparation of the research site for patient enrollment, including staff training, protocol review, and equipment setup?

16. Perform 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 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. GPV 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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