Clinical Research Associate

Alira Health

Clinical Research Associate monitoring clinical trials for Alira Health’s global clinical research team. Ensuring GCP compliance, site quality, data integrity, and sponsor deliverables.

Posted 8/25/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesJuniorMid-Level💰 $85,000 - $130,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial monitoring, ensuring compliance with ICH GCP, FDA regulations, and company SOPs. Proficient in managing study budgets, conducting site visits, and providing oversight to CRA teams while maintaining strong relationships with sponsors and site personnel.

Highest-signal resume keywords

Clinical Trial MonitoringICH GCP ComplianceStudy Budget ManagementSite Relationship ManagementLeadership and Mentoring

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site MonitoringProtocol ComplianceQuality ControlData Integrity VerificationETMF/TMF DocumentationInvestigational Product AccountabilityMonitoring Visit ReportingStudy-Specific Monitoring PlansRegulatory Binder ReviewAdverse Event Reporting

Soft Skills

Organizational SkillsProblem-SolvingCommunication SkillsInterpersonal SkillsNegotiation Skills

Tools & Technologies

Clinical Trial Management SystemsClinical Trial DatabasesElectronic Data Capture

Industry Keywords

Clinical ResearchFDA RegulationsEthical RequirementsSponsor RelationsCross-Functional Collaboration

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 the management and execution of clinical trials
Ensure protocol compliance and quality
Work with Lead CRAs, Senior CRAs, in-house CRAs, clinical monitoring leadership, and Project Managers
Address site questions and assist with study recruitment, site training, and site-related issues
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 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 documentation and site contract negotiation
Provide monthly billing information to the finance team
Manage study budgets and act as sponsor referent for stand-alone monitoring projects
Perform qualification, initiation, interim, and close-out visits remotely and onsite
Prepare accurate and timely monitoring visit reports
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 regular contact with study sites 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 to maintain consistency and teamwork
Assist with CRA new-hire training and onboarding
Mentor CRAs
Collaborate on CTMS development and maintenance
Manage conflicting priorities and deliver commitments
Perform additional assigned duties

Requirements

What you’ll need

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 and ability to multi-task 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 who thrives in a collaborative, less structured team environment
Knowledge of clinical research, ICH GCP, and local regulations
Knowledge of regulatory and ethical requirements
Adequate English for EU roles
Bachelor of Science in Biology or Life Sciences

Benefits

Comp & perks

Remote work arrangement
Opportunities for collaboration across global teams and time zones