Clinical Study Assistant

Regeneron Pharmaceuticals • Armonk, NY

1d • $34 - $56 • Hybrid

About The Position

Regeneron is seeking a Clinical Study Assistant to support the Clinical Sciences team in initiating, maintaining, and closing clinical trials across all phases. The role helps keep studies compliant, organized, and on track, supporting study execution from start-up through closeout and working with colleagues across internal departments. The position is primarily on-site in Armonk, NY, or Warren, NJ, with hybrid flexibility and up to 25% travel possible.

Requirements

• General understanding of the clinical research process and regulations and 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.

Nice To Haves

• BS/BA in a life science or nursing degree preferred.
• 0–1 year of relevant experience.

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 quality-check 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 or notarization of trial documents.
• Partner with internal departments to exchange information needed to meet study goals.
• Use sound judgment to resolve routine issues and escalate complex matters to appropriate 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 team processes.
• Seek out new assignments to learn and grow.

Benefits

• Student Loan Paydown program
• Tuition reimbursement
• Family Care Benefits
• Relocation assistance
• Inclusion, Culture and Well-Being programs, including physical and mental health
• Competitive and comprehensive total rewards package that may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed