Clinical Trial Operations Coordinator (Hybrid)

Regeneron Pharmaceuticals, Inc (USA); Armonk (NY); On-site; USD 47,000 - 77,000; Full time

Benefits offered by this job

Student Loan Paydown program & Tuition

Family Care Benefits

Relocation Assistance

Inclusion, Culture and Well-Being

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a Clinical Study Assistant to join the Clinical Sciences team in Armonk, NY. You will support the study team from start-up through close-out, maintain study documents, and coordinate meetings and materials for sites worldwide.

This role requires a BS/BA in a life science or nursing and 0–1 year of relevant experience, with strong Microsoft Office skills and attention to detail. On-site with hybrid flexibility and up to 25% travel.

Qualifications

• BS/BA in a life science or nursing degree preferred and 0-1 year of relevant experience.
• General understanding of the clinical research process and regulations/guidelines, familiarity with medical terminology.
• Proficiency with Microsoft Office, including Excel and PowerPoint.
• Strong time management, attention to detail, and written and verbal communication skills.

Responsibilities

• Support the Clinical Study Lead and study team with all aspects of study execution, from start-up through close-out.
• Collect, review, and track site regulatory documents and start-up activities using established study tools.
• Review, maintain, and QC essential study documents in the electronic Trial Master File (eTMF) according to the TMF plan.
• Keep the clinical trial management system (CTMS) accurate and up to date, and monitor clinical trial results posting requirements.
• Schedule and coordinate team meetings, and prepare and file agendas and minutes.
• Assemble study binders, reference manuals, and training and Investigator Meeting materials, and distribute materials to study sites.
• Track study close-out activities, including FDA Form 1572s, investigational product reconciliation, and financial disclosures.
• Support submissions to internal review committees, consulting agreements, study-level financial requisitions, and Apostille/notary of trial documents.
• Partner with internal departments to exchange the information needed to meet study goals.
• Use sound judgment to resolve routine issues and elevate complex matters to the right team members.
• Work accurately and stay organized while multitasking in a fast‑paced setting where priorities can shift quickly.
• Learn and apply company policies, SOPs, and quality and compliance standards, including GCP, ICH, and CFR requirements.
• Communicate clearly, build strong relationships, and contribute ideas to improve how the team works.
• Seek out new assignments to learn and grow.

Skills

Microsoft Office

Excel

PowerPoint

Time management

Written & verbal communication

Education

BS/BA in life science or nursing

Tools

eTMF

CTMS

Job description

Regeneron Pharmaceuticals, Inc (USA) is seeking a Clinical Study Assistant to join the Clinical Sciences team in Armonk, NY. You will support the study team from start-up through close-out, maintain study documents, and coordinate meetings and materials for sites worldwide.

This role requires a BS/BA in a life science or nursing and 0–1 year of relevant experience, with strong Microsoft Office skills and attention to detail. On-site with hybrid flexibility and up to 25% travel.