Clinical Research Associate

Alira Health

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

Posted 8/25/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesJuniorMid-Level💰 $85,000 - $115,000 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 ActivitiesLeadership Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchProtocol ComplianceQuality ControlData Integrity VerificationSite MonitoringRegulatory Binder ReviewAdverse Event ReportingETMF/TMF ManagementStudy-Specific Monitoring PlansInvestigator Site Visits

Soft Skills

Organizational SkillsProblem-SolvingInterpersonal SkillsCommunication SkillsNegotiation Skills

Tools & Technologies

Clinical Trial Management SystemsElectronic Data CaptureClinical Trial Databases

Certifications & Qualifications

Certified MonitorBachelor of Science in Biology or Life Sciences

Industry Keywords

Clinical TrialsSOPsFDA RegulationsEthics Document CollectionPatient AccrualCross-Functional CollaborationSite Contract NegotiationMonitoring Visit ReportsScientific MeetingsCRO Compliance

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 negotiate and 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 accurate monitoring visit reports documenting site problems, resolutions, protocol deviations, study progress, and enrollment
Review source documents and verify CRF data integrity
Perform quality control and verification of eTMF/TMF documents
Conduct investigational product accountability
Review site regulatory binders
Maintain contact with study sites to ensure protocol/GCP compliance 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
Collaborate with in-house CRAs, CTC, and data management to resolve discrepant data queries
Identify site issues and develop problem-solving strategies
Conduct audit preparation at study sites as needed
Collaborate with other CRAs to maintain consistency and teamwork
Assist with CRA new-hire training and onboarding
Mentor CRAs
Collaborate on development and maintenance of the CTMS
Manage conflicting priorities and deliver on commitments
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; 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
EU: Adequate English
Bachelor of Science in Biology or Life Sciences

Benefits

Comp & perks

Remote work
Regular employment contract