Clinical Research Associate

Alira Health

. Conduct site monitoring responsibilities for clinical trials .

Posted 10/5/2026part-timeRemote • Massachusetts • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in conducting site monitoring for clinical trials, ensuring compliance with ICH GCP, FDA regulations, and local regulations. Proficient in managing study budgets, providing oversight to CRA teams, and maintaining effective communication with sponsors and study sites.

Highest-signal resume keywords

Clinical Trial MonitoringICH GCP ComplianceBudget ManagementCRA Team LeadershipRegulatory Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site MonitoringQuality ControlData VerificationClinical Trial Management SystemsElectronic Data CaptureSource Document ReviewAdverse Event ReportingProblem-Solving StrategiesStudy-Specific Monitoring PlansInvestigator Site Visits

Soft Skills

Organizational SkillsInterpersonal SkillsAnalytical SkillsNegotiation SkillsCommunication Skills

Tools & Technologies

Clinical Trial Management SystemsClinical Trial DatabasesETMF/TMF Documents

Certifications & Qualifications

Certified MonitorBachelor of Science (BS) in Biology or Life Sciences

Industry Keywords

Clinical ResearchRegulatory RequirementsEthical RequirementsSponsor RelationshipsProject Management

About the role

Key responsibilities & impact

Conduct site monitoring responsibilities for clinical trials
Provide oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality
Provide guidance, oversight, and feedback to the CRA team regarding project scope, SOPs, timelines, and budgets
Review monitoring visit reports and conduct co-monitoring and evaluation visits as needed
Ensure appropriate and 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 accurate and timely monitoring visit reports
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, 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
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 Clinical Trial Management System (CTMS) development and maintenance
Manage conflicting priorities and deliver 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 the 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 Local language, both written and verbal, in the country where monitoring activities are performed
Excellent communication and interpersonal skills with customer service orientation
Good computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data capture
Self-starter who thrives in a collaborative, yet 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 (BS) in Biology or Life Sciences

Benefits

Comp & perks

Remote work arrangement
Part-time employment
Contingency Workforce contract type