Senior Clinical Research Associate - FS

Location: United States of America; the role includes continuous onsite monitoring and up to 70-85% travel.

Company

hirify.global provides functional services for biotech, medtech, and specialty pharmaceutical companies developing medicines, devices, and diagnostics.

What you will do

• Conduct source verification by comparing case report forms with source documents and reviewing informed consent forms, regulatory records, and device accountability documentation.
• Investigate and resolve data discrepancies, document visit reports, and escalate issues appropriately.
• Identify, document, and report non-compliance and reportable events according to protocols, regulations, and applicable requirements.
• Manage study contracts and collect, review, and approve investigator and site documentation.
• Negotiate budgets with clinical trial sites.

Requirements

• Bachelor's degree or international equivalent, preferably in a clinical, biological, scientific, or health-related field, or an equivalent combination of education, training, and experience.
• 5-7 years of practical experience conducting independent onsite monitoring of clinical research sites and site management activities, or proven experience in the primary job functions.
• Knowledge of ICH/GCP and/or ISO 14155 requirements and relevant country-specific clinical trial regulations.
• Strong analytical and organizational skills, with the ability to work independently and manage multiple projects in a changing environment.
• Experience with Schedule 1 is required.
• Willingness to travel up to 70-85%.

Culture & Benefits

• Opportunities for professional growth, skills development, and career advancement.
• Flexible working practices designed to support work-life balance.
• Employee ideas and feedback contribute to how work is performed.
• Equal opportunity employment compliant with applicable federal guidelines.