Senior Clinical Research Associate (Cell & Gene Therapy)

TL;DR

Senior Clinical Research Associate (Cell & Gene Therapy): Overseeing clinical monitoring and site management for cell and gene therapy trials with an accent on GCP compliance and regulatory requirements. Focus on conducting on-site and remote monitoring, ensuring protocol adherence, and managing site-patient data integrity.

Location: Remote (US)

Company

hirify.global is a service provider specializing in early access programs, clinical trial supply, and patient site solutions worldwide.

What you will do

• Lead site feasibility activities, including distributing questionnaires, conducting SQVs, and recommending sites.
• Conduct SIVs, routine monitoring, and close-out visits in accordance with protocol, ICH-GCP, and regulatory requirements.
• Verify source data and CRFs for accuracy and consistency to ensure site files are audit-ready.
• Review IP accountability and safety event documentation, driving corrective and preventative actions for protocol deviations.
• Manage data queries, analyze error trends, and provide targeted retraining to site staff.
• (For Lead roles) Develop study-specific monitoring documents (CMP), train other CRAs, and act as the primary monitoring contact for sponsors.

Requirements

• Bachelor’s degree in life sciences, nursing, or a related field.
• 5–7+ years of experience in conducting on-site and remote monitoring visits.
• Direct experience in Cell & Gene Therapy monitoring is required.
• Solid understanding of medical terminology and ICH-GCP regulatory standards.
• Proficiency with EDC systems and MS Office.
• Ability to travel up to 80%.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance including FSA and HSA.
• 401K safe harbor plan with company match.
• Paid vacation, holidays, sick time, and parental leave.
• Voluntary life and disability insurance (short-term and long-term).
• A commitment to diversity, equity, and inclusion (DEI) with opportunities for professional growth.