Clinical Research Associate

Alira Health

. Conduct site monitoring responsibilities for clinical trials .

Posted 10/5/2026full-timeRemote • Massachusetts • United StatesJuniorMid-Level💰 $100,000 - $130,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in clinical trial monitoring, ensuring protocol compliance, quality control, and effective communication with cross-functional teams. Proficient in managing study budgets, conducting site visits, and adhering to ICH GCP and FDA regulations.

Highest-signal resume keywords

Clinical Trial MonitoringICH GCP ComplianceStudy Budget ManagementSite Visit CoordinationCross-Functional Team Leadership

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Monitoring Visit ReportsSource Document ReviewETMF/TMF VerificationInvestigational Product AccountabilityClinical Trial Management SystemsData Integrity VerificationAdverse Event ReportingProblem-Solving StrategiesSite Contract NegotiationStudy-Specific Monitoring Plans

Soft Skills

Organizational SkillsInterpersonal SkillsAnalytical SkillsNegotiation SkillsCustomer Service Orientation

Tools & Technologies

Clinical Trial DatabasesElectronic Data CaptureClinical Trial Management System

Industry Keywords

Clinical ResearchFDA RegulationsRegulatory RequirementsEthical RequirementsSponsor Relationships

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
Ensure protocol compliance and quality
Work with Lead CRAs, Senior CRAs, in-house CRAs, Associate Director of Clinical Monitoring, and Project Managers
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
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
Set up and collect site-specific ethics documents and assist with site contract negotiation
Provide monthly billing information to the finance team
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 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, assess patient accrual, and respond to sponsor requests
Ensure compliance with ICH GCP, FDA regulations, and company/sponsor 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 onboarding, training, and mentoring
Collaborate on the development and maintenance of the Clinical Trial Management System (CTMS)
Manage conflicting priorities and perform additional assigned duties

Requirements

What you’ll need

2+ years 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 multi-task 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

Benefits

Comp & perks

Remote and onsite work options for monitoring visits
Regular employment contract
Global, collaborative work environment
Opportunities for CRA mentoring and training
Professional development through participation in internal, client/sponsor, scientific, and other meetings