Lead Clinical Research Associate

Alira Health

Lead Clinical Research Associate providing oversight and guidance in clinical trial monitoring at Alira Health. Ensuring compliance and quality while collaborating with cross-functional teams in clinical research.

Posted 5/16/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work, Alira Health SOPs and regulatory requirements
May perform Central Monitoring activities, or act as the primary liaison between site and Central Monitor
Collaborate with cross-functional teams and CRAs to maintain high standards of clinical trial conduct
Conducts investigational product (IP) inventory and accountability, while evaluating storage conditions and access protocols
Confirms IP has been dispensed and administered to participants in compliance with the study protocol
Leverages expertise in GCP, local regulations and Alira Health procedures
Reviews the Investigator Site File (ISF) for audit readiness including accuracy and completeness
Reconciles the ISF with the Trial Master File (TMF)
Performs quality checks on regulatory documents per ALCOA+ principles
Supports audit readiness by submitting documents to the TMF
Verification and review of safety events
Prepares accurate monitoring visit reports and communication logs in alignment with Alira Health SOPs and the Clinical Monitoring Plan timelines
Participants in internal, client/sponsor, scientific, and other meetings as required
Oversees Clinical Research Associates (CRAs) to ensure monitoring visits are conducted within the timelines specific in the Clinical Monitoring Plan
Monitors site and CRA performance to maintain SDV rates within study goal range
Works closely with Project Managers, CRAs and Data Management to resolve CRF queries on discrepant data

Requirements

What you’ll need

Dedicated and results oriented with a bachelor’s degree in a relevant field (sciences, nursing, medical preferred)
Preferred 7+ years’ experience in the clinical research or health industry fields
Clinical monitoring experience required in the pharmaceutical, biotech, medtech or CRO industries
People and study management experience required
Expertise in data management, site management and monitoring, including proficiency in clinical trial software and tools
Committed to quality with a proven track record of being thorough and detail-oriented in ensuring protocol adherence and data integrity
Strong analytical, negotiation, meeting management, cross-functional team collaboration, and leadership skills to drive successful trial outcomes
Willing and able to travel up to 85% to support site visits and project needs
In-depth knowledge of ICH GCP and ISO 14155 guidelines, along with local regulatory requirements
Experience in people and study management
Strong command of English, and the local language as necessary, both written and verbal

Benefits

Comp & perks

Professional development
Global travel
Flexible work programs

ATS Keywords

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Hard Skills & Tools

clinical monitoringdata managementsite managementmonitoring visit reportsregulatory document quality checksinvestigational product inventoryaudit readinessprotocol adherencesafety event verificationclinical trial software

Soft Skills

dedicatedresults orienteddetail-orientedanalyticalnegotiationmeeting managementcross-functional team collaborationleadershippeople managementstudy management

Certifications

GCPISO 14155