Clinical Research Associate - Regulatory & Site Trials

Alira Health; Massachusetts; On-site; USD 50,000 - 70,000; Full time

Job summary

Alira Health in Massachusetts seeks a Clinical Research Associate to support regulatory submissions, site startup, and data management across trial sites. You will develop ICF templates, assist with IRB submissions, and ensure TMF compliance under ICH-GCP guidelines.

Requires a BS/BA and 1–2 years in clinical research; strong English communication and MS Office skills are essential. This is an on-site US role.

Qualifications

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

Responsibilities

• Develops study documents and tools, including ICF templates for local and central IRBs.
• Supports sites in IRB approvals and submission materials.
• Responds to regulatory board requests for protocol and ICF clarification.
• Ensures regulatory documents and TMF are complete and filed.
• Analyzes site performance and provides training for sites.
• Maintains communication with study sites for protocol/GCP compliance.

Skills

Detail-oriented

Organizational skills

Analytical skills

Communication skills

MS Office proficiency

Education

Bachelor of Arts (BA)

Bachelor of Science (BS)

Tools

MS Office Suite

Word

Excel

Job description

Alira Health in Massachusetts seeks a Clinical Research Associate to support regulatory submissions, site startup, and data management across trial sites. You will develop ICF templates, assist with IRB submissions, and ensure TMF compliance under ICH-GCP guidelines.

Requires a BS/BA and 1–2 years in clinical research; strong English communication and MS Office skills are essential. This is an on-site US role.