Senior Clinical Site Navigator – Senior Start-up Specialist

Job Overview:

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.

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) AND 4 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations.
• 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 guidelines and RA, IRB/IEC regulations will be considered.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Advanced English level
   

Experience (Minimum Required):

• More than 4 years of experience in clinical development or regulatory process.
• In depth experience of applying strong knowledge of ICH, RA, IRB/IEC and other applicable regulations/guidelines. Expert knowledge of investigator start-up documents; previous interaction with operational project teams and investigative sites.
• In depth experience of issue escalation and resolution.
• Credible role model in effective communication and problem solving.
• Proven strengths managing relationships and negotiating solutions while maintaining a level of approachability with colleagues both internal and external to the organization.
• Strategic thinking.
• Team Leadership.
• Coping with Complexity.
• Business acumen.
• Oversight.
• Matrix competence.
• Emotional Intelligence.
• Resilience.
• Diversity orientation/cultural awareness.
• Quality/Service leadership.
• Focus on Customers.
• Innovate and Change.
• Work Well with Others.
• Develop Self and Teams.
• Gets it Done.

Physical Demands/Work Environment:

• General Office Environment.

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