Remote In-House Clinical Research Associate

Alira Health; Framingham (MA); Hybrid; USD 50,000 - 70,000; Full time

Job summary

Alira Health is seeking an In-House Clinical Research Associate to support clinical sites from approval through close-out, with minimal travel and strong collaboration with field CRAs and PMs. This role emphasizes site regulatory management and data integrity in a fast-paced environment.

Ideal candidates hold a BA/BS and 1–2 years in clinical research, with excellent English communication, meticulous attention to detail, and the ability to multi-task across studies using MS Office tools.

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 Informed Consent Form (ICF) templates for local and central IRBs.
• 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.

Skills

Attention to detail

Organizational skills

Analytical thinking

Cross-functional collaboration

Communication skills

Problem-solving

English proficiency

Customer service orientation

Leadership potential

Education

BA/BS degree

Equivalent experience

Tools

MS Office

Excel

Word

Job description

Alira Health is seeking an In-House Clinical Research Associate to support clinical sites from approval through close-out, with minimal travel and strong collaboration with field CRAs and PMs. This role emphasizes site regulatory management and data integrity in a fast-paced environment.

Ideal candidates hold a BA/BS and 1–2 years in clinical research, with excellent English communication, meticulous attention to detail, and the ability to multi-task across studies using MS Office tools.