Clinical Research Associate, In-House (Biotech)

Location: On site in Dunkirk, NY, United States. Monday–Friday during standard business hours, with flexibility subject to manager approval.

Annual base pay: $85,000–$93,000, depending on qualifications, experience, and geographic location. Eligible for a discretionary bonus and equity award.

Company

hirify.global is a commercial-stage biotechnology company developing immunotherapy, cell therapy, cancer vaccine, and infectious disease treatments designed to strengthen the natural immune system.

What you will do

• Support clinical research teams with study start-up, feasibility, site activation, and inspection-readiness activities.
• Create, collect, review, and file essential regulatory documents in the Trial Master File and maintain expected document lists and study metrics.
• Support CTMs and CPMs by triaging site inquiries, coordinating with field CRAs, and tracking protocol and eligibility-related issues.
• Coordinate clinical specimen logs, shipments, central laboratory requirements, non-investigational supplies, and investigational product metrics.
• Support supplier oversight, site payment processes, invoice reconciliation, purchase requisitions, and clinical site records in the ERP system.
• Support safety reporting, clinical study report documentation, medical writing activities, presentations, and cross-functional clinical operations projects.

Requirements

• Bachelor’s degree with 4+ years of Clinical Trials Associate experience or 7+ years of clinical research experience; alternatively, an associate degree with 7+ years of Clinical Trials Associate experience or 10+ years of clinical research experience.
• Knowledge of the drug development process, ICH E6, and the Code of Federal Regulations.
• Computer literacy with EDC, eTMF, CTMS, Microsoft Word, Excel, PowerPoint, Outlook, and Adobe.
• Strong written and verbal communication, organization, prioritization, multitasking, independent decision-making, and problem-solving skills.
• Ability to work independently and collaboratively while maintaining corporate confidentiality and identifying process gaps.
• Ability to work on site in Dunkirk, NY, use standard office equipment, and lift and carry materials weighing up to 20 pounds.

Culture & Benefits

• Collaborative work across different areas of a growing, publicly traded biopharmaceutical company.
• Professional development opportunities and exposure to next-generation cancer and infectious disease therapies.
• Medical, dental, and vision plan options, health and financial wellness programs, and an employee assistance program.
• Life, AD&D, short-term and long-term disability coverage, flexible spending accounts, 401(k) with company match, and a 529 education savings program.
• Paid time off, holidays, wellness resources, legal services, identity theft protection, pet insurance, discounts, rewards, and other perks.