Hybrid Senior In-house Clinical Research Associate

at Alira Health

• Job title: Senior In-house Clinical Research Associate
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Boston, United States

About the role

• Sr. In-house CRA managing and supporting clinical sites from approval to close-out for Alira Health. Collaborating with field CRAs to ensure trial data integrity without frequent travel.

Responsibilities

• Develops study documents and tools, including Informed Consent Form (ICF) templates (for both local and central IRBs), Investigator Site File (ISF) 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) as needed
• 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

• BS/BA from an undergraduate program or equivalent experience
• At least 7 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

• Professional development
• Global travel
• Flexible work programs