In-House Clinical Research Associate (Contract) (Gene Therapy)

Location: Remote, United States; travel required as business needs demand, anticipated at less than 5%.

Hourly compensation: $60.00–$70.00 per hour, with the final rate depending on geographical location, experience, skills, and years of experience.

Company

hirify.global is a biotechnology company developing targeted gene therapies using proprietary AAV vectors and its Therapeutic Vector Evolution platform.

What you will do

• Support Phase 3 clinical trial execution across start-up, conduct, and close-out activities.
• Act as a primary contact for assigned clinical sites and CRO field CRAs, resolving issues and supporting study timelines.
• Review monitoring reports, track action items and deliverables, and escalate unresolved findings.
• Maintain study tracking tools covering site activation, enrollment, visits, essential documents, TMF status, and vendor reconciliation.
• Collect and quality-check regulatory documents, file records in the TMF/eTMF, and support audits and inspection readiness.
• Coordinate study meetings, prepare materials, document minutes, and maintain action-item logs.

Requirements

• Bachelor’s degree required.
• 1–2 years of experience supporting clinical trials in a sponsor or CRO environment.
• Working knowledge of clinical trial operations and ICH GCP guidelines.
• Experience with TMF/eTMF systems; Veeva Vault experience is preferred.
• Proficiency with Microsoft Office and strong organizational, communication, and prioritization skills.
• Ability to collaborate with cross-functional teams, clinical sites, and external partners.

Nice to have

• Experience supporting Phase 3 clinical trials.
• Ophthalmology experience.

Culture & Benefits

• Remote work arrangement within the United States.
• Collaborative, team-oriented environment focused on gene therapy innovation.
• Opportunities for career development and challenging clinical operations work.
• Equal employment opportunity protections apply.