Clinical Research Associate

Alira Health

. Conduct site monitoring responsibilities for clinical trials .

Posted 10/5/2026full-timeRemote • Massachusetts • United StatesJuniorMid-Level💰 $100,000 - $130,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial monitoring, ensuring protocol compliance, quality control, and adherence to regulatory requirements. Proficient in managing cross-functional teams, mentoring, and maintaining strong relationships with study sites and sponsors.

Highest-signal resume keywords

Clinical Trial MonitoringProtocol ComplianceQuality ControlRegulatory KnowledgeCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Monitoring Visit ReportsSource Document VerificationETMF/TMF ManagementAdverse Event ReportingClinical Trial Management SystemsElectronic Data CaptureProblem-Solving StrategiesStudy Site AuditsData Integrity MaintenanceNegotiation Skills

Soft Skills

Organizational SkillsInterpersonal SkillsCommunication SkillsLeadership SkillsStress Management

Tools & Technologies

Clinical Trial Management SystemsClinical Trial DatabasesElectronic Data Capture

Industry Keywords

ICH GCPClinical ResearchRegulatory RequirementsEthical RequirementsBachelor of Science in Biology or Life Sciences

About the role

Key responsibilities & impact

Conduct site monitoring responsibilities for clinical trials
Provide oversight, leadership, and guidance in clinical trial management and execution
Ensure protocol compliance, quality, and adherence to 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, training presentations, ethics documents, and site contract negotiation
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
Verify source documents and maintain CRF data integrity
Perform quality control and document verification for eTMF/TMF
Conduct investigational product accountability and review regulatory binders
Maintain contact with study sites regarding protocol/GCP compliance, accrual rates, and sponsor requests
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
Prepare study sites for audits
Mentor CRAs and assist with CRA onboarding and training
Collaborate on CTMS development and maintenance
Manage conflicting priorities and perform additional assigned duties

Requirements

What you’ll need

2+ years monitoring experience required
Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members
Ability to autonomously manage monitoring activities
Quality focused; proven ability to be careful, thorough, and detail-oriented
Strong organizational skills and 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
Knowledge of clinical research, ICH GCP, and local regulations
Knowledge of regulatory and ethical requirements
English
Bachelor of Science (BS) in Biology or Life Sciences