Senior Clinical Trial Associate (CAR-T Oncology)

Location: Hybrid role based in Somerset, New Jersey, United States; applicants must be authorized to work in the United States.

Company

hirify.global is a biotechnology company developing cell therapies, including CAR-T, TCR-T, and natural killer cell-based treatments for life-threatening diseases.

What you will do

• Support the day-to-day execution of complex Phase I and Phase II CAR-T oncology clinical trials.
• Prepare, organize, and maintain regulatory files, Trial Master Files, eTMFs, and study correspondence.
• Coordinate investigator meetings, site visits, study team meetings, agendas, minutes, and action items.
• Track site activation, enrollment, monitoring activities, study milestones, and operational deliverables.
• Support regulatory and IRB/IEC submissions, data query tracking, and data reconciliation.
• Coordinate communication among clinical teams, CROs, vendors, and investigational sites while identifying and escalating operational risks.

Requirements

• Bachelor’s degree in life sciences, clinical research, or a related field.
• 3–5 years of experience as a Clinical Trial Associate or in a similar clinical research role.
• Oncology clinical trial experience is required. Cell therapy or CAR-T experience is strongly preferred.
• Experience with trial coordination, regulatory documentation, site management, ICH-GCP, and applicable regulatory requirements.
• Proficiency with CTMS, eTMF, EDC, and Microsoft Office Suite.
• Strong organization, communication, analytical, problem-solving, and cross-functional collaboration skills.

Nice to have

• CRC or CRA certification.
• Cell therapy and/or CAR-T clinical trial experience.

Culture & Benefits

• Permanent full-time employees are eligible for hirify.global benefits.
• Contractors are not eligible for benefits through hirify.global.
• Employment eligibility is verified through Form I-9 and E-Verify.
• Work within a growing, cross-functional Clinical Operations organization focused on innovative cell therapies.