Clinical Research Associate – Wound Care

Alira Health

. Conduct site monitoring responsibilities for clinical trials .

Posted 10/14/2026full-timeBoston • Massachusetts • United StatesJuniorMid-Level💰 $90,000 - $130,000 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 ethical standards. Proficient in monitoring activities, budget management, and cross-functional collaboration to drive successful trial execution.

Highest-signal resume keywords

Clinical Trial ManagementICH GCP ComplianceWound Care Monitoring ExperienceBudget ManagementCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchProtocol ComplianceMonitoring Visit ReportsData Integrity VerificationETMF/TMF Quality ControlInvestigational Product AccountabilitySite Contract NegotiationAdverse Event ReportingProblem-Solving StrategiesStudy-Specific Monitoring Plans

Soft Skills

Strong Organizational SkillsExcellent Communication SkillsInterpersonal SkillsLeadership SkillsAbility to Manage Stress

Tools & Technologies

Clinical Trial Management SystemsClinical Trial DatabasesElectronic Data Capture

Industry Keywords

FDA RegulationsLocal RegulationsEthical RequirementsSponsor RelationshipsPatient Accrual

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 clinical trial quality
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 study-specific Monitoring Plans and training presentations
Set up and collect site-specific ethics documents and assist with 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 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 contact with study sites regarding 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 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
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

2+ years wound care 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; 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 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; ability to use 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 language
Bachelor of Science (BS) in Biology or Life Sciences

Benefits

Comp & perks

Remote work arrangement
Regular employment contract
Global team collaboration
Referral application opportunity