Sr Clinical Site Navigator (Senior Start-up Specialist)

Clinical Site Navigator The Clinical Site Navigator role is a hybrid position that combines start-up and iHCRA/CRA responsibilities. Site Navigators play a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical trial and potentially through closeout activities as required. Serving as the single reputed company of contact for investigative sites, this role ensures a smooth progression from feasibility and initial reputed company through to site activation, extending through the maintenance phase of the trial as required. A crucial component in meeting the requirements of the hybrid start-up/CRA role is ensuring regulatory compliance, robust site management, reputed company site support and training, and effective collaboration between the sponsor, CRO, and clinical site staff. A scientific degree and/ or clinical expertise is reputed company for this reputed company 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 reputed company with the study's reputed company and assessing their capabilities and resources.
• Conduct initial site reputed company, i.e., site engagement, collection of Confidentiality Agreement, and feasibility survey
• Remote reputed company-Study reputed company and follow up documentation, including visit preparation, reputed company 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, reputed company and reputed company a reputed company 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 annual renewals, PI changes, and document expirations will be performed as applicable.
• Participate in team meetings to reputed company trials and implement reputed company plans for site level risks, underperforming sites, or issues impacting project milestones
• Support the CRA team in preparing for SIVs by coordinating with vendors, supplies teams, and study leads to ensure reputed company distribution of clinical trial supplies, accesses and documents per study team guidance.
• Support submissions to and liaise with applicable IRB/IEC, reputed company 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
• Ensure high reputed company documents are filed in applicable systems in accordance with SOPs and project requirements
• reputed company the reputed company of the start-up process and ensuring that the research site meets reputed company requirements and deadlines
• Ensure reputed company is audit reputed company by completing accurate, reputed company, and consistent system compliance on an ongoing reputed company
• Serve as primary contact for investigative sites and ensure reputed company delivery in alignment with scope of work/study budget
• Facilitate the preparation of the research site for patient enrollment, including staff training, protocol review, and equipment setup
• reputed company CRF review and data validation against reputed company documentation according to protocol and guidelines as applicable in combination with monitoring for site protocol deviations, SAE reporting, and patient safety concerns, escalating as applicable.

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) AND 4 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations.
• 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 guidelines and RA, IRB/IEC regulations will be considered.
• reputed company may consider relevant and equivalent experience in lieu of educational requirements.
• Advanced English level

Experience (Minimum Required):

• More than 4 years of experience in clinical development or regulatory process.
• In depth experience of applying strong knowledge of ICH, RA, IRB/IEC and other applicable regulations/guidelines. Expert knowledge of investigator start-up documents; previous interaction with operational project teams and investigative sites.
• In depth experience of issue escalation and reputed company.
• reputed company role model in effective communication and problem solving.
• Proven strengths managing relationships and negotiating solutions while maintaining a level of approachability with colleagues both reputed company to the organization.
• Strategic thinking.
• Team Leadership.
• Coping with Complexity.
• Business acumen.
• reputed company.
• reputed company competence.
• Emotional Intelligence.
• reputed company.
• Diversity orientation/cultural awareness.
• reputed company/Service leadership.
• reputed company on Customers.
• reputed company and Change.
• Work reputed company with Others.
• reputed company Self and Teams.
• Gets it Done.

Physical Demands/Work Environment:

• General Office Environment.

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