In-House Clinical Research Associate

Alira Health; United States; Remote; USD 50,000 - 70,000; Full time

Job summary

Alira Health is seeking an In-house CRA in the United States to support clinical sites from approval through close-out, with minimal travel. The role partners with field CRAs and Project Managers to ensure trial data integrity while maintaining regulatory compliance and timely communications.

The candidate will develop study documents, support IRB submissions, and manage TMF documentation, with 1–2 years in clinical research and permanent US work authorization.

Qualifications

• BS/BA from an undergraduate program or equivalent experience.
• 1–2 years of experience in clinical research.
• Permanent authorization to work in the U.S.

Responsibilities

• Develops study documents and tools, including ICF templates for local and central IRBs.
• Supports sites in obtaining IRB approval and developing submission materials.
• Ensures regulatory documents are collected and filed in TMF; conducts routine file reviews.
• Maintains site communications to ensure protocol and GCP compliance.
• Reviews eCRFs remotely and resolves data queries with Data Management.
• Assists with recruiting investigative sites for clinical studies.
• Complies with ICH GCP guidelines, FDA regulations, and company SOPs.

Skills

Detail-oriented

Organizational skills

Analytical skills

Communication skills

MS Office

English proficiency

Education

BS/BA

Job description

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

Job Description

ROLE

The In-house CRA is an important member of the Alira Health Clinical team. In-house CRAs manage and support clinical sites from site approval through close-out. In-house CRAs work closely with field CRAs and Clinical Project Managers to ensure the integrity of the trial data without the need for frequent travel.

KEY RESPONSIBILITIES

• 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

DESIRED QUALIFICATION & EXPERIENCE

• BS/BA from an undergraduate program or equivalent experience
• 1-2 years of experience in clinical research

TECHNICAL COMPETENCES & SOFT SKILLS

• 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.

Languages

English

Education

Bachelor of Arts (BA), Bachelor of Science (BS)

Contract Type

Regular

Salary Range

The final offer will be determined within the applicable location-specific range and will depend on the candidate’s confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope.

$50,000 - $70,000 Annually