Description
Senior Site Navigators play a critical role in coordinating site-level activities throughout the start-up phase of a clinical study and potentially through closeout activities as required.
As a Senior Site Navigator, you will serve as the single point of contact for investigative sites, ensuring smooth progression from feasibility and initial outreach through to site activation, extending through the maintenance phase of the study as required.
Summary of Responsibilities:
- Oversee site level tasks associated with efficient site activation in accordance with ICH/GCP guidelines, local regulations, SOPs, and project requirements
- Identify potential research sites that align with the study's criteria and assess their capabilities and resources
- Conduct initial site outreach, collect Confidentiality Agreements, and feasibility surveys
- Support customization and translation of informed consent forms and patient-facing materials
- Collect, track, and perform quality reviews of 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 by coordinating with vendors, supplies teams, and study leads
- Perform initial contract and budget negotiations with sites
- Ensure high-quality documents are filed in applicable systems and the Trial Master File is updated and audit-ready
- Track the progress of the start-up process and ensure research sites meet all requirements and deadlines
- Serve as primary contact for investigative sites and ensure timely delivery in alignment with scope of work/study budget
- Perform Case Review Form (CRF) review and data validation against source documentation
Qualifications (Minimum Required):
- University/College degree (life science preferred), or certification in a related allied health profession, or 3-5 years' work experience in clinical research
- Fluent in local official language and in English, both written and verbal
Experience (Minimum Required):
- Minimum of 3+ years of experience in clinical development or start-up/regulatory process
- Thorough knowledge of ICH/GCP, RA, IRB/IEC, and other applicable regulations/guidelines
- Demonstrated understanding of research protocol requirements and proven ability to communicate them
- Effective communication with various stakeholders, including site staff, CRO personnel, and regulatory authorities
Physical Demands / Work Environment:
- Remote-based work required with possible office presence depending on location
- Travel requirements: Limited for training only