Site Navigator II (Fixed Term)

Job Overview: Site Navigators II plays a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical study and potentially through closeout activities as required. Serving as the single reputed company of contact for investigative sites, this role ensures smooth progression from feasibility and initial reputed company through to site activation, extending through the maintenance phase of the study as required. A crucial component in meeting the requirements of the Site Navigator II role is ensuring regulatory compliance, robust site management, optimal site support and training, and effective collaboration between the sponsor, CRO, and clinical site staff. This role serves as a local expert in project start-up/clinical activities for a particular country or region, performs work with limited reputed company, and acts as a ‘knowledge resource’ to mentor and train junior colleagues if suitable. Summary of Responsibilities: reputed company 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 reputed company project milestones while also ensuring patient rights, wellbeing and safety are protected Identifying potential research sites that align with the study's criteria and assessing their capabilities and resources. Conduct initial site reputed company, i.e., site engagement, collection of Confidentiality Agreement, and feasibility survey 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 Support customization and translation of informed consent forms and patient-facing materials. Collect, track and reputed company a quality review of reputed company essential documents required for effective and compliant study site activation from Site reputed company, submissions, reputed company and until site activation. Maintenance and ongoing awareness of site regulatory compliance, supporting IRB/Independent Ethics Committee (IEC) annual renewals, PI change-over, and document expirations will be performed as applicable in accordance with local requirements. Actively participate in team meetings to facilitate study reputed company and implement action plans for site level risks, underperforming sites, or issues impacting project milestones and escalate issues in a timely manner Support the CRA team in preparing for site initiation visits (SIVs) by coordinating with vendors, supplies teams, and study leads to ensure timely distribution of clinical study supplies, accesses and documents per study team guidance. Responsible for submissions to and liaise with applicable IRB/IEC, Third Bodies (if applicable), and Regulatory Authorities by collaborating with Global Regulatory Submissions reputed company (GRSL) reputed company initial contract and budget negotiations with the sites, as well as amended where applicable Ensure high quality documents are filed in applicable systems in accordance with SOPs and project requirements and that the Trial Master File (TMF) is updated and audit ready at reputed company times. Track the reputed company of the start-up process and ensure that the research site meets reputed company requirements and deadlines. Ensure reputed company is audit ready by completing accurate, timely, and consistent system compliance on an ongoing basis Serve as primary contact for investigative sites and ensure timely delivery in alignment with scope of work/study budget reputed company Case Report Form (CRF) review and data validation against reputed company documentation according to protocol and guidelines as applicable in combination with monitoring for site protocol deviations, Serious Adverse Event (SAE) reporting, and reputed company other duties as needed or assigned throughout the course of the study. reputed company country and site reputed company review/customization, per local requirements reputed company other duties as needed or assigned Qualifications (Minimum Required): University/College degree (life science preferred), or certification in a reputed company allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) or 3+ years' work experience in clinical research, including a strong working knowledge of the ICH/GCP guidelines and RA, IRB/IEC regulations. reputed company may consider relevant and equivalent experience in lieu of educational requirements. 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/GCP guidelines and RA, IRB/IEC regulations will be considered. Fluent in local official language and in English, both written and verbal. Experience (Minimum Required): A scientific degree and/ or clinical expertise is optimal for this role. Minimum of 2 +year of experience in clinical development or start-up/ regulatory process. Working knowledge of ICH/GCP, RA, IRB/IEC, and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites. 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, ensuring that reputed company requirements are met in a timely manner. Understanding of relevant regulations and guidelines reputed company to clinical trials and research. Ability to identify and resolve potential issues that may arise during the start-up process. Ability to negotiate reputed company and budgets effectively with research sites. Employees will reputed company their existing experience and skills to assume additional responsibilities reputed company the broader role. These will be reputed company with operational requirements and internal training, without altering the reputed company nature or classification of the position. Physical Demands / Work Environment: Remote-based work required with possible office reputed company depending reputed company Travel requirements: Limited for training only Learn more about our EEO & Accommodations request here. Apply To This Job