Clinical Research Associate

Alira Health

. Conduct site monitoring responsibilities for clinical trials .

Posted 10/5/2026full-timeBoston • Massachusetts • United StatesJuniorMid-Level💰 $115,000 - $135,000 per yearWebsite

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 high-quality standards in clinical research.

Highest-signal resume keywords

Clinical Trial ManagementICH GCP ComplianceBudget ManagementMonitoring ActivitiesCross-Functional Coordination

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site MonitoringProtocol ComplianceQuality ControlData Integrity VerificationAdverse Event ReportingClinical Trial DatabasesElectronic Data CaptureStudy Budget ManagementInvestigator Site VisitsRegulatory Binder Review

Soft Skills

Organizational SkillsProblem-SolvingAnalytical SkillsCommunication SkillsInterpersonal Skills

Tools & Technologies

Clinical Trial Management SystemsETMF/TMF

Industry Keywords

Clinical ResearchFDA RegulationsEthical RequirementsSponsor RelationshipsSite Contract Negotiation

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, 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 documentation, 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 accurate monitoring visit reports documenting site issues, resolutions, protocol deviations, study progress, and enrollment
Verify source documents and CRF data integrity
Perform quality control and document verification for eTMF/TMF
Conduct investigational product accountability
Review site regulatory binders
Maintain site contact for protocol/GCP compliance, patient accrual, and sponsor requests
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 CRAs/CTC and data management
Identify site issues and develop problem-solving strategies
Conduct audit preparation at study sites
Mentor and train CRAs and support new-hire onboarding
Collaborate on CTMS development and maintenance
Manage conflicting priorities and 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; proven ability to be careful, thorough, and detail-oriented
Strong organizational skills and ability to multitask 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
English language
Bachelor of Science (BS) in Biology or Life Sciences