Remote-First In-House Clinical Research Associate

Alira Health; Boston, Northern (MA, KY); Hybrid; USD 50,000 - 70,000; Full time

Job summary

Alira Health in the United States is seeking an In-house CRA to join our Clinical team. The role manages and supports clinical sites from site approval through close-out, with limited travel and close collaboration with field CRAs and Clinical Project Managers.

You will ensure data integrity, help prepare ICFs and regulatory submissions, review eCRFs remotely, and assist with site performance and training to support trials.

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.
• Languages English

Responsibilities

• Develops study documents and tools, including ICF templates for local and central IRBs.
• Supports sites in obtaining IRB approval and preparing submission materials.
• Responds to sites’ regulatory board requests for protocol and ICF clarifications.
• Ensures all regulatory documents are in place prior to investigational product shipment.
• Ensures regulatory documents are filed in TMF and conducts routine file reviews.
• Analyzes site performance issues and provides training for study sites.
• Maintains regular communication with study sites to ensure protocol compliance.
• Conducts remote review of data entered on eCRFs.
• Resolves queries on discrepant data with field CRAs and data management.

Skills

Attention to detail

Organizational skills

Multi-tasking

Analytical thinking

Cross-functional collaboration

Leadership

Problem-solving

Communication skills

English proficiency

Education

BS/BA

Tools

MS Word

MS Excel

Job description

Alira Health in the United States is seeking an In-house CRA to join our Clinical team. The role manages and supports clinical sites from site approval through close-out, with limited travel and close collaboration with field CRAs and Clinical Project Managers.

You will ensure data integrity, help prepare ICFs and regulatory submissions, review eCRFs remotely, and assist with site performance and training to support trials.