Clinical Research Associate

Alira Health

. Conduct site monitoring responsibilities for clinical trials .

Posted 10/5/2026full-timeRemote • Massachusetts • United StatesJuniorMid-Level💰 $110,000 - $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 SOPs while effectively managing study budgets and site relationships. Proficient in problem-solving, quality control, and cross-functional collaboration to drive successful trial execution.

Highest-signal resume keywords

Clinical Trial MonitoringICH GCP ComplianceStudy Budget ManagementCross-Functional CollaborationProblem-Solving Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site MonitoringProtocol ComplianceQuality ControlData VerificationAdverse-Event ReportingETMF/TMF ManagementClinical Trial Management SystemsElectronic Data CaptureStudy-Specific Monitoring PlansRegulatory Binder Review

Soft Skills

Organizational SkillsInterpersonal SkillsAnalytical SkillsNegotiation SkillsLeadership Skills

Industry Keywords

Clinical ResearchFDA RegulationsLocal RegulationsEthical RequirementsSponsor Relationships

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 and quality
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 study-specific Monitoring Plans and training presentations
Assist with ethics-document collection and site contract negotiation
Provide monthly billing information to Finance
Manage study budgets and act as sponsor referent for stand-alone projects
Perform qualification, initiation, interim, and close-out visits remotely and onsite
Prepare monitoring visit reports documenting site problems, resolutions, protocol deviations, study progress, and enrollment
Review and verify source documents and CRF data
Perform quality control and verification of eTMF/TMF documents
Conduct investigational product accountability
Review site regulatory binders
Maintain contact with study sites regarding protocol/GCP compliance, accrual, and sponsor requests
Ensure compliance with ICH GCP, FDA regulations, and 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
Assist with CRA training and onboarding; mentor CRAs
Collaborate on CTMS development and maintenance
Manage conflicting priorities and deliver commitments

Requirements

What you’ll need

2+ years monitoring experience
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
Able 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
Bachelor's degree in Biology, Life Sciences, or equivalent listed education