Alira Health

Research Analyst

• Manage and support clinical sites from site approval through close-out
• Develop study documents and tools, including Informed Consent Form (ICF) templates
• Support sites in obtaining IRB approval, developing submission materials, and creating site-specific ICFs
• Ensure all required site regulatory documents and approvals are in place prior to investigational product shipment
• Conduct routine file reviews and ensure all regulatory documents are collected and filed appropriately
• Analyze site performance problems and identify solutions; provide ongoing training for study sites
• Conduct remote review of data entered on electronic Case Report Forms (eCRFs) as needed
• Maintain regular communication with study sites to ensure protocol/GCP compliance
• Conduct internal, client/sponsor, scientific, and other meetings as required
• Perform additional duties as assigned

Senior In-House Clinical Research Associate

• Manage and support clinical sites from site approval through close-out
• Develops study documents and tools, including Informed Consent Form (ICF) templates
• Supports sites in obtaining IRB approval, developing submission materials, and creating site-specific ICFs
• Responds to sites’ regulatory board requests for protocol and ICF clarification as needed
• Ensures all required site regulatory documents and approvals are in place prior to investigational product shipment
• Analyzes site performance problems (protocol adherence) and identifies solutions
• Maintains regular communication with study sites to ensure protocol/GCP compliance
• Conducts remote review of data entered on electronic Case Report Forms (eCRFs)
• Assists with efforts to recruit investigative sites to participate in clinical studies
• Complies with ICH GCP guidelines, FDA regulations, and company SOPs

In-House Clinical Research Associate

• Perform site monitoring visits in accordance with contracted scope of work
• Collaborate with cross-functional teams and CRAs to maintain high standards
• Conducts investigational product inventory and accountability
• Reviews the Investigator Site File for audit readiness
• Prepares accurate monitoring visit reports and communication logs
• Provides guidance, oversight, and feedback to the study team
• Oversee Clinical Research Associates to ensure monitoring visits are conducted within timelines

Lead Clinical Research Associate

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits)
• Collaborate with cross-functional teams and CRAs to maintain high standards of clinical trial conduct
• Conduct investigational product (IP) inventory and accountability
• Consistently prepares accurate monitoring visit reports and communication logs
• Assists in CRA new hire training and onboarding

Clinical Research Associate

Project Manager

• Manages clinical research studies to ensure studies are conducted in accordance with approved scope of work/budget, ICH GCP guidelines, and FDA regulations and within established timelines
• Serves as study lead and primary contact for sponsors
• Manages clinical study functions, which may include investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory
• Generates and presents frequent study status updates and reports to sponsor
• Supervises and provides support to the Clinical team, including Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates
• Supervises and trains Associate PMs
• Creates and reviews clinical study documents, including protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, site binders, etc
• Drives and facilitates clinical teamwork and communications to ensure timely attainment of trial milestones
• Ensures accuracy of reports and material work product
• Provides monthly billing information to finance team
• Presents at project meetings such as investigator meetings and new client meetings
• Updates management accurately and regularly through frequent communication
• Identifies issues and develops problem-solving strategies to ensure study timelines are met
• Manages subject accrual, retention, and compliance
• Assists in TMF management and manages TMF reviews as needed
• Prepares for and participates in third-party audits and FDA inspections
• Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company SOPs
• Participates in internal, client/sponsor, scientific, and other meetings as required
• Performs additional duties as assigned.