Description
Job Overview
The Site Navigators II role plays a critical part in coordinating site-level activities during the start-up phase of a clinical study and potentially through closeout activities. As the single point of contact for investigative sites, this role ensures smooth progression from feasibility and initial outreach through to site activation and maintenance phases of the study. The role requires ensuring regulatory compliance, robust site management, optimal site support and training, and effective collaboration between the sponsor, CRO, and clinical site staff.
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, including site engagement, collection of Confidentiality Agreement, and feasibility survey.
- Perform remote Pre-Study Visits and follow-up documentation.
- 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 team meetings to facilitate study progress and implement action plans for site-level risks or issues.
- Support the CRA team in preparing for site initiation visits (SIVs).
- Responsible for submissions to and liaison with applicable IRB/IEC, Third Bodies (if applicable), and Regulatory Authorities.
- Perform initial contract and budget negotiations with the sites.
- Ensure high-quality documents are filed in applicable systems and that the Trial Master File (TMF) is updated and audit-ready at all times.
- Track the progress of the start-up process and ensure that the research site meets all requirements and deadlines.
- Serve as primary contact for investigative sites and ensure timely delivery in alignment with the scope of work/study budget.
- Perform Case Report 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+ years' work experience in clinical research.
- Fluent in local official language and in English, both written and verbal.
Experience (Minimum Required):
- 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.
- 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.
- Understanding of relevant regulations and guidelines related to clinical trials and research.
Physical Demands / Work Environment:
- Remote-based work required with possible office presence depending on location.
- Travel requirements: Limited for training only.