Description
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 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.
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.
- Apply independent judgment and discretion in managing site-level activities, resolving issues, and making decisions that support study timelines and compliance requirements.
- 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 quality reviews of essential documents required for effective and compliant study site activation.
- 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.
- Liaise with applicable IRB/IEC, Third Bodies, and Regulatory Authorities.
- 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 the 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.
Qualifications:
- University/College degree (life science preferred) or certification in a related allied health profession.
- 2-3 years' work experience in clinical research, including knowledge of ICH/GCP guidelines and RA, IRB/IEC regulations.
- Fluent in local official language and in English, both written and verbal.
Experience:
- At least one year of experience in a related field (e.g., medical, clinical, pharmaceutical, laboratory research).
- Basic knowledge of ICH/GCP, RA, IRB/IEC, and other applicable regulations/guidelines.
- Demonstrated understanding of research protocol requirements and effective communication with various stakeholders.
Physical Demands / Work Environment:
- Remote-based work required with possible office presence depending on location.
- Travel requirements: Limited to training only.