In-House Clinical Research Associate – 2

Alira Health

In-house Clinical Research Associate managing clinical sites for Alira Health. Ensuring trial data integrity and collaborating with field CRAs and Clinical Project Managers.

Posted 5/21/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesJuniorMid-Level💰 $55,000 - $70,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Develops study documents and tools, including Informed Consent Form (ICF) templates (for both local and central IRBs), site binder contents, etc.
Supports sites in obtaining IRB approval, developing submission materials, and creating site-specific ICFs
Responds to sites’ regulatory board requests for protocol and ICF clarification as needed
Ensures all required site regulatory documents and approvals are in place prior to investigational product shipment
Ensures all regulatory documents are collected and filed appropriately at both the site and in the Trial Master File (TMF); conducts routine file reviews
Analyzes site performance problems (protocol adherence) and identifies solutions; provides ongoing training for study sites
Maintains regular communication with study sites to ensure protocol/GCP compliance, assesses subject accrual rates, and responds to sponsor requests
Conducts remote review of data entered on electronic Case Report Forms (eCRFs)
Works closely with field CRAs and data management to resolve queries on discrepant data
Assists with efforts to recruit investigative sites to participate in clinical studies
Complies with ICH GCP guidelines, FDA regulations, and company SOPs
Participates in internal, client/sponsor, scientific, and other meetings as required
Manages and resolves conflicting priorities to deliver on commitments
Performs additional duties as assigned

Requirements

What you’ll need

BS/BA from an undergraduate program or equivalent experience
1-2 years of experience in clinical research
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
Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
Self-starter who thrives in a collaborative, yet less structured team environment
Ability to problem-solve unstructured or ambiguous challenges
Strong command of English, both written and verbal
Excellent communication and interpersonal skills with customer service orientation
Proficient with MS Office Suite, particularly Word and Excel
Permanent authorization to work in the U.S.

Benefits

Comp & perks

Professional development
Global travel
Flexible work programs

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical researchprotocol adherencedata analysiseCRFIRB approvalGCP complianceregulatory documentationsubmission materialssite-specific ICFsTrial Master File

Soft Skills

detail-orientedorganizational skillsmulti-taskinganalytical skillsnegotiation skillsmeeting managementleadership skillsproblem-solvingcommunication skillsinterpersonal skills