Clinical Research Associate

Alira Health

Clinical Research Associate monitoring clinical trials for Alira Health’s global healthcare research team. Ensuring site compliance, data integrity, regulatory adherence, and study quality.

Posted 8/25/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial management, ensuring compliance with ICH GCP, FDA regulations, and SOPs while effectively coordinating cross-functional teams. Proficient in monitoring activities, budget management, and maintaining strong relationships with sponsors and site personnel.

Highest-signal resume keywords

Clinical Trial ManagementICH GCP ComplianceBudget ManagementSite MonitoringCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchProtocol ComplianceData Integrity VerificationQuality ControlMonitoring Visit ReportsSite Contract NegotiationAdverse Event ReportingETMF/TMF ManagementInvestigational Product AccountabilityCRF Data Verification

Soft Skills

Organizational SkillsProblem-SolvingLeadershipCommunicationInterpersonal Skills

Tools & Technologies

Clinical Trial Management SystemsClinical Trial DatabasesElectronic Data Capture

Certifications & Qualifications

Certified MonitorBachelor's Degree in Biology or Life Sciences

Industry Keywords

Clinical TrialsRegulatory RequirementsEthical RequirementsSponsor RelationshipsPatient Accrual

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Conduct site monitoring responsibilities for clinical trials independently
Provide oversight, leadership, and guidance in clinical trial management and execution
Ensure protocol compliance, quality, adherence to SOPs, timelines, and budget requirements
Review monitoring visit reports and conduct co-monitoring and evaluation visits as needed
Ensure timely investigator site visits
Coordinate cross-functional departments to resolve clinical trial monitoring issues
Assist with Monitoring Plans and training presentations
Set up and collect site ethics documents and assist with site contract negotiation
Provide monthly billing information to the finance team
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 issues, 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, assess patient accrual, and respond to sponsor requests
Ensure compliance with ICH GCP, FDA regulations, and company/sponsor SOPs
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
Train and onboard new CRAs and mentor CRAs
Collaborate on CTMS development and maintenance
Manage conflicting priorities and perform additional assigned duties

Requirements

What you’ll need

EU: Graduation in a scientific health field
EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011
Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members
Ability to autonomously manage monitoring activities
Quality focused; careful, thorough, and detail-oriented
Strong organizational skills; ability to multi-task and work effectively in a fast-paced environment
Ability to manage priorities, organize time, and solve problems
Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
Ability to travel
Ability to manage stress
Professional, trustworthy, and disciplined
Ability to problem-solve unstructured or ambiguous challenges
Strong command of the local language, written and verbal, in the country where monitoring activities are performed
Excellent communication and interpersonal skills with customer service orientation
Good computer skills, including clinical trial management systems, clinical trial databases, and electronic data capture
Self-starter able to thrive in a collaborative, less structured team environment
Knowledge of clinical research, ICH GCP, and local regulations
Knowledge of regulatory and ethical requirements
EU: Adequate English
Bachelor's degree in Biology or Life Sciences

Benefits

Comp & perks

Remote work arrangement
Global team collaboration across time zones