In-House Clinical Research Associate – Remote Collaboration

Alira Health; United States; Remote; USD 50.000 - 70.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Detail-oriented

Organizational skills

Analytical skills

Communication skills

MS Office

English proficiency

Ausbildung

BS/BA

Jobbeschreibung

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.