Alira Health

Research Analyst

• Develops study documents and tools, including Informed Consent Form (ICF) templates (for both local and central IRBs), site binder contents, etc.
• 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
• Ensures all regulatory documents are collected and filed appropriately at both the site and in the Trial Master File (TMF); conducts routine file reviews
• Analyzes site performance problems (protocol adherence) and identifies solutions; provides ongoing training for study sites
• Maintains regular communication with study sites to ensure protocol/GCP compliance, assesses subject accrual rates, and responds to sponsor requests
• Conducts remote review of data entered on electronic Case Report Forms (eCRFs)
• Works closely with field CRAs and data management to resolve queries on discrepant data
• Assists with efforts to recruit investigative sites to participate in clinical studies
• Complies with ICH GCP guidelines, FDA regulations, and company SOPs
• Participates in internal, client/sponsor, scientific, and other meetings as required
• Manages and resolves conflicting priorities to deliver on commitments
• Performs additional duties as assigned

In-House Clinical Research Associate – 2

• 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 and developing submission materials
• Respond to sites’ regulatory board requests for protocol and ICF clarification
• Ensure all required site regulatory documents are in place prior to investigational product shipment
• Conduct routine file reviews and analyze site performance problems
• Maintain regular communication with study sites to ensure compliance
• Conduct remote review of data entered on electronic Case Report Forms (eCRFs)
• Assist with efforts to recruit investigative sites to participate in clinical studies
• Comply with ICH GCP guidelines and FDA regulations
• Participate in internal, client/sponsor, scientific, and other meetings as required
• Manage and resolve conflicting priorities to deliver on commitments

In House Clinical Research Associate

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work, Alira Health SOPs and regulatory requirements
• May perform Central Monitoring activities, or act as the primary liaison between site and Central Monitor
• Collaborate with cross-functional teams and CRAs to maintain high standards of clinical trial conduct
• Conducts investigational product (IP) inventory and accountability, while evaluating storage conditions and access protocols
• Confirms IP has been dispensed and administered to participants in compliance with the study protocol
• Leverages expertise in GCP, local regulations and Alira Health procedures
• Reviews the Investigator Site File (ISF) for audit readiness including accuracy and completeness
• Reconciles the ISF with the Trial Master File (TMF)
• Performs quality checks on regulatory documents per ALCOA+ principles
• Supports audit readiness by submitting documents to the TMF
• Verification and review of safety events
• Prepares accurate monitoring visit reports and communication logs in alignment with Alira Health SOPs and the Clinical Monitoring Plan timelines
• Participants in internal, client/sponsor, scientific, and other meetings as required
• Oversees Clinical Research Associates (CRAs) to ensure monitoring visits are conducted within the timelines specific in the Clinical Monitoring Plan
• Monitors site and CRA performance to maintain SDV rates within study goal range
• Works closely with Project Managers, CRAs and Data Management to resolve CRF queries on discrepant data

Lead Clinical Research Associate

Attorney

• Assist the legal team by reviewing, analyzing, and uploading the current backlog of commercial executed contracts to One Contracts.
• Quickly review executed contracts to ensure completeness, proper formatting, and legibility prior to uploading.
• Accurately log key metadata (e.g., effective dates, renewal dates, parties involved, and obligations).
• Upload those contracts to One Contracts by following the system's requirements for accurate record-keeping.

Legal Intern

• Conduct site monitoring responsibilities for clinical trials
• Provide oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality
• Ensure appropriate and timely investigator site visits
• Provide guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements
• Review monitoring visit reports, conduct co-monitoring and evaluation visits as needed
• Prepare consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status
• Participate in internal, client/sponsor, scientific, and other meetings as required

Senior Clinical Research Associate

• Conduct site monitoring responsibilities for clinical trials
• Provide oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality
• Ensure appropriate and timely investigator site visits
• Review monitoring visit reports, conduct co-monitoring and evaluation visits as needed
• Prepare consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status
• Maintain regular contact with study sites to ensure protocol/GCP compliance, assess patient accrual rates, and respond to sponsor requests
• Participate in internal, client/sponsor, scientific, and other meetings as required