Alira Health

Clinical Research

• Conduct site monitoring responsibilities for clinical trials independently
• Provide oversight, leadership, and guidance in the management and execution of clinical trials
• Guide, oversee, and provide feedback to the CRA team regarding project scope, SOPs, timelines, and budgets
• Review monitoring visit reports and conduct co-monitoring and evaluation visits as needed
• Ensure appropriate and timely investigator site visits
• Coordinate cross-functional departments to resolve clinical trial monitoring issues
• Assist with study-specific Monitoring Plans and training presentations
• Assist with ethics-document collection and site contract negotiation
• Provide monthly billing information to finance
• Manage study budgets and act as sponsor referent for stand-alone projects
• Perform qualification, initiation, interim, and close-out visits remotely and onsite
• Prepare accurate monitoring visit reports covering site problems, resolutions, protocol deviations, study progress, and enrollment
• Conduct source document review and verification to ensure CRF data integrity
• Perform quality control and verification of eTMF/TMF documents
• Conduct investigational product accountability
• Review site regulatory binders
• Maintain regular site contact to ensure protocol/GCP compliance and assess patient accrual
• Ensure compliance with ICH GCP, FDA regulations, and company/Sponsor SOPs
• Participate in internal, client/sponsor, scientific, and other meetings
• Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs
• Resolve discrepant-data queries with in-house CRAs/CTC and data management
• Identify site issues and develop problem-solving strategies
• Conduct audit preparation at study sites
• Support CRA collaboration and consistency
• Assist with CRA new-hire training and onboarding
• Mentor CRAs
• Collaborate on development and maintenance of the Clinical Trial Management System (CTMS)
• Manage conflicting priorities and deliver on commitments
• Perform additional assigned duties

Senior Clinical Research Associate

• Conduct site monitoring responsibilities for clinical trials independently
• Provide oversight, leadership, and guidance to CRA teams
• Ensure adherence to project scope, SOPs, timelines, budgets, protocol, GCP, and regulatory requirements
• Review monitoring visit reports and conduct co-monitoring and evaluation visits
• Ensure timely investigator site visits
• Coordinate cross-functional issue resolution for clinical trial monitoring
• Assist with Monitoring Plans, training presentations, ethics documents, and site contract negotiation
• Provide monthly billing information to finance
• Manage study budgets and act as sponsor referent for stand-alone projects
• Perform qualification, initiation, interim, and close-out visits remotely and onsite
• Prepare accurate monitoring visit reports covering site issues, resolutions, protocol deviations, study progress, and enrollment
• Verify source documents and CRF data integrity
• Perform quality control of eTMF/TMF documents and investigational product accountability
• Review site regulatory binders
• Maintain site contact, assess patient accrual, and respond to sponsor requests
• Facilitate adverse event reporting and SAE reconciliation
• Resolve discrepant data queries with in-house CRAs, CTC, and data management
• Identify site issues and develop problem-solving strategies
• Prepare study sites for audits
• Mentor and train CRAs, including new-hire onboarding
• Collaborate on CTMS development and maintenance
• Manage conflicting priorities and perform additional assigned duties

Clinical Trial Coordinator

• Assist the clinical research team, supporting Project Managers, Study Start-up team, Clinical Research Associates, and clinical sites to ensure studies comply with ICH GCP, applicable laws, SOPs, and protocols while respecting budgets and timelines
• Conduct site identification and feasibility activities, including outreach, follow-up, and circulation/collection of feasibility questionnaires and NDAs
• Support internal, client/sponsor, scientific, and other meetings through scheduling, agenda preparation, and meeting minutes
• Perform site start-up activities, including Ethics Committee, Institutional Review Board, and regulatory submissions, plus site contract and budget negotiation
• Maintain relationships with Ethics Committees and Competent Authorities
• Set up, maintain, and perform quality control of Trial Master Files
• Support Investigator Site File preparation and distribution
• Support management of study site supplies
• Support collection and review of site Essential Documents with CRAs
• Communicate with sites regarding questions, protocol/GCP compliance, study progress, and subject accrual
• Support study management throughout the study lifecycle, including project reports, CTMS updates, and study-specific trackers
• Maintain study team training materials
• Support site/vendor invoicing management
• Support CRA follow-up activities
• Support document translation
• Participate in audits
• Perform additional assigned duties

• Conduct site monitoring responsibilities for clinical trials independently
• Provide oversight, leadership, and guidance in the management and execution of clinical trials
• Ensure protocol compliance and quality
• Collaborate with clinical monitoring, CRA, in-house CRA, data management, project management, and sponsor teams
• Assist with study recruitment, site training, and site-related issues
• Provide guidance, oversight, and feedback to the CRA team
• Review monitoring visit reports and conduct co-monitoring and evaluation visits
• Ensure appropriate and timely investigator site visits
• Coordinate cross-functional departments to resolve clinical trial monitoring issues
• Assist with study-specific Monitoring Plans and training presentations
• Assist with ethics documents and site contract negotiation
• Provide monthly billing information to finance
• Manage study budgets and act as sponsor referent for stand-alone projects
• Perform qualification, initiation, interim, and close-out visits remotely and onsite
• Prepare accurate and timely monitoring visit reports
• Review and verify source documents and CRF data
• Perform quality control and verification of eTMF/TMF documents
• Conduct investigational product accountability
• Review site regulatory binders
• Maintain contact with study sites regarding protocol/GCP compliance, patient accrual, and sponsor requests
• Participate in internal, client/sponsor, scientific, and other meetings
• Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs
• Resolve discrepant data queries with in-house CRAs/CTC and data management
• Identify site issues and develop problem-solving strategies
• Conduct audit preparation at study sites
• Assist with CRA new hire training and onboarding
• Mentor CRAs
• Collaborate on development and maintenance of the CTMS
• Manage conflicting priorities and deliver on commitments
• Perform additional assigned duties

• Conduct site monitoring responsibilities for clinical trials independently
• Provide oversight, leadership, and guidance in the management and execution of clinical trials
• Ensure protocol compliance and quality
• Provide guidance, oversight, and feedback to the CRA team regarding project scope, SOPs, timelines, and budgets
• Review monitoring visit reports and conduct co-monitoring and evaluation visits
• Ensure timely investigator site visits
• Coordinate cross-functional departments to resolve clinical trial monitoring issues
• Assist with Monitoring Plans and training presentations
• Assist with ethics documents and site contract negotiation
• Provide monthly billing information to finance
• Manage study budgets and act as sponsor referent for stand-alone projects
• Perform qualification, initiation, interim, and close-out visits remotely and onsite
• Prepare monitoring visit reports documenting site problems, resolutions, protocol deviations, study progress, and enrollment
• Review source documents and verify CRF data integrity
• Perform quality control and document verification for eTMF/TMF
• Conduct investigational product accountability
• Review site regulatory binders
• Maintain contact with study sites regarding protocol/GCP compliance, patient accrual, and sponsor requests
• Ensure compliance with ICH GCP, FDA regulations, and company/sponsor SOPs
• Participate in internal, client/sponsor, scientific, and other meetings
• Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs
• Resolve discrepant data queries with CRAs/CTC and data management
• Identify site issues and develop problem-solving strategies
• Conduct audit preparation at study sites
• Assist with CRA training and onboarding
• Mentor CRAs
• Collaborate on Clinical Trial Management System (CTMS) development and maintenance
• Manage conflicting priorities and deliver on commitments
• Perform additional assigned duties

• Conduct site monitoring responsibilities for clinical trials independently
• Provide oversight, leadership, and guidance in the management and execution of clinical trials
• Ensure protocol compliance and quality
• Provide guidance, oversight, and feedback to the CRA team regarding project scope, SOPs, timelines, and budgets
• Review monitoring visit reports and conduct co-monitoring and evaluation visits
• Ensure appropriate and timely investigator site visits
• Coordinate cross-functional departments to resolve clinical trial monitoring issues
• Assist with study-specific Monitoring Plans and training presentations
• Assist with ethics documents and site contract negotiation
• Provide monthly billing information to finance
• Manage study budgets and act as sponsor referent for stand-alone projects
• Perform qualification, initiation, interim, and close-out visits remotely and onsite
• Prepare accurate monitoring visit reports documenting site problems, resolutions, actions, protocol deviations, study progress, and enrollment
• Ensure CRF data integrity through source document review and verification
• Perform quality control and verification of site documents for eTMF/TMF
• Conduct investigational product accountability
• Review site regulatory binders
• Maintain contact with study sites to ensure protocol/GCP compliance and assess patient accrual
• Ensure compliance with ICH GCP, FDA regulations, and company/Sponsor SOPs
• Participate in internal, client/sponsor, scientific, and other meetings
• Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs
• Resolve discrepant data queries with in-house CRAs/CTC and data management
• Identify site issues and develop problem-solving strategies
• Conduct audit preparation at study sites
• Collaborate with other CRAs
• Assist in CRA new-hire training and onboarding
• Mentor CRAs
• Collaborate on the development and maintenance of the CTMS
• Manage conflicting priorities and deliver on commitments
• Perform additional assigned duties

Consultant

• Execute HEOR projects for global and local clients
• Develop global cost-effectiveness models, budget impact models, local adaptations of global models, and early models for strategic decision-making
• Own assigned projects and deliver project components within agreed timelines and quality standards
• Manage project execution and develop approaches to client needs
• Coordinate client and stakeholder engagements, lead meetings, and report on project execution
• Guide and review quantitative and qualitative analyses
• Identify and communicate potential project issues and challenges
• Coordinate reports, presentations, workshops, and other client deliverables
• Ensure quality, timeliness, and accuracy of complex deliverables
• Develop life sciences and healthcare industry knowledge through engagements and training
• Provide oversight and direction to team members
• Support business development from lead discovery through proposal defense
• Contribute to internal strategic projects, knowledge management, technology systems, and related functions
• Manage, coach, and coordinate Associates and Analysts
• Support sales presentations, quotes, and proposals
• Support recruitment and oversee onboarding of new employees
• Support thought leadership projects, including white papers, publications, and specialized conferences
• Develop internal HEOR delivery and proposal resources and external abstracts, posters, manuscripts, and white papers

Senior Clinical Research Associate

Senior Clinical Research Associate

Clinical Trial Coordinator

Senior Clinical Research Associate

Senior Clinical Research Associate

Senior Clinical Research Associate

Senior Consultant, Global HEOR