Site Navigator I

Accountabilities: Site Identification and Feasibility: Identify potential investigative sites that meet study requirements, assess their capabilities and resources, conduct initial outreach, obtain confidentiality agreements, and coordinate feasibility questionnaires. Site Start-Up and Activation: Coordinate site-level start-up activities from feasibility through activation, tracking milestones, deadlines, submissions, and outstanding requirements to ensure timely study initiation. Regulatory Compliance and Documentation: Collect, review, track, and maintain essential site documents in accordance with ICH/GCP guidelines, applicable regulations, standard operating procedures, and study-specific requirements. Pre-Study Visits: Coordinate remote pre-study visits, including preparation, follow-up activities, visit reports, and supporting documentation required for site selection and activation. Regulatory Submissions: Prepare and coordinate submissions to Institutional Review Boards (IRBs), Independent Ethics Committees (IECs), applicable third parties, and regulatory authorities in collaboration with the relevant regulatory submissions team. Informed Consent Management: Review and support the customization and translation of informed consent forms and patient-facing materials to meet country-specific and local regulatory requirements. Site Maintenance and Regulatory Oversight: Monitor document expirations, annual ethics committee renewals, principal investigator changes, and other ongoing compliance requirements throughout the study, as applicable. Contract and Budget Coordination: Conduct initial contract and budget negotiations with investigative sites and support amendments when required, ensuring alignment with study scope and budget expectations. Cross-Functional Collaboration: Work closely with project leadership, Clinical Research Associates (CRAs), study leads, sponsors, CRO personnel, vendors, and site staff to coordinate deliverables and resolve operational issues. Site Initiation Support: Assist CRA teams in preparing for site initiation visits by coordinating clinical supplies, system access, documentation, and other site readiness requirements. Risk Management and Escalation: Participate in study team meetings, identify site-level risks and performance issues, develop action plans, and escalate concerns promptly to protect project timelines and study quality. Trial Master File Management: Ensure accurate, timely, and consistent filing of essential documents in applicable systems and maintain an audit-ready Trial Master File (TMF). Clinical Data Quality and Monitoring Support: Perform Case Report Form (CRF) reviews and data validation against source documentation, as applicable, while supporting the identification of protocol deviations, serious adverse event reporting requirements, and other study compliance matters. Operational Excellence: Exercise independent judgment in managing site activities, resolving issues, prioritizing competing deadlines, and completing additional responsibilities in line with operational requirements and internal training. Requirements Education: A university or college degree, preferably in life sciences, or a relevant qualification in an allied health profession, such as nursing, medical technology, or laboratory technology. Equivalent relevant professional experience may be considered. Alternative Qualification Pathway: Candidates with a high school diploma or equivalent and at least five years of clinical research experience, including strong knowledge of applicable regulations, may also be considered. Professional Experience: At least one year of experience in a related field, such as clinical research, healthcare, pharmaceuticals, laboratory research, data analysis, data management, or technical writing. Previous clinical research experience is preferred. Clinical Research Knowledge: Basic understanding of ICH/GCP guidelines, regulatory authority requirements, IRB/IEC processes, and applicable clinical trial regulations. Site Start-Up Experience: Familiarity with investigator site start-up documentation, feasibility assessments, regulatory submissions, site activation processes, and contract and budget negotiations is advantageous. Protocol Understanding: Ability to interpret clinical study protocols and understand their implications for site readiness, documentation, compliance, and study execution. Documentation and Quality Control: Strong attention to detail and the ability to review, organize, track, and maintain accurate regulatory and essential study documents. Communication Skills: Excellent written and verbal communication skills in English and the applicable local official language, with the ability to communicate effectively with site personnel, sponsors, CRO teams, and regulatory stakeholders. Organization and Time Management: Ability to manage multiple projects, competing priorities, and strict deadlines while maintaining accuracy and consistency. Problem-Solving and Judgment: Strong analytical skills and the ability to identify potential site start-up challenges, resolve routine issues, and escalate complex concerns appropriately. Negotiation and Coordination: Ability to support contract and budget negotiations, coordinate cross-functional activities, and maintain productive relationships with investigative sites. Compliance Mindset: Commitment to patient rights, safety, confidentiality, regulatory compliance, and the ethical conduct of clinical research. Remote Work Readiness: Ability to work effectively in a remote environment and collaborate with geographically distributed clinical research teams. Benefits Remote Work: Remote-based working arrangement, with possible office attendance depending on location. Limited Travel: Travel requirements are limited primarily to training. Professional Development: Opportunity to strengthen expertise in clinical trial start-up, regulatory documentation, site management, and clinical research operations. Cross-Functional Exposure: Work collaboratively with sponsors, CRO teams, investigators, regulatory stakeholders, and clinical operations professionals. Career Growth: Opportunity to develop clinical research knowledge and take on additional responsibilities aligned with operational needs and internal training. Meaningful Impact: Contribute to the successful delivery of clinical studies while supporting participant safety, regulatory compliance, and research quality. Compensation and Additional Benefits: Salary, healthcare coverage, paid leave, and other benefits were not specified in the original job description and should be confirmed during recruitment.