Clinical Study Assistant

Regeneron Pharmaceuticals • Warren, MI

7d • Hybrid

About The Position

Regeneron is seeking a Clinical Study Assistant to support its Clinical Sciences team in the initiation, maintenance, and closeout of clinical trials across all phases. The role helps ensure studies remain compliant, organized, and on track for patients worldwide. It is based in Armonk, New York, or Warren, New Jersey, and is primarily on-site with hybrid flexibility. Travel of up to 25% may be required.

The assistant supports the Clinical Study Lead and study team with study execution from start-up through closeout. The role involves managing study and site documentation, maintaining clinical systems and records, coordinating meetings and materials, tracking closeout tasks, and working with internal departments. The assistant is expected to follow company policies, SOPs, and quality and compliance requirements, including GCP, ICH, and CFR requirements, while communicating effectively and managing shifting priorities.

Requirements

• General understanding of the clinical research process and applicable 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.
• Ability to stay organized and work accurately while multitasking in a fast-paced setting with shifting priorities.

Nice To Haves

• Bachelor of Science or Bachelor of Arts degree in a life science or nursing.

Responsibilities

• Support the Clinical Study Lead and study team with study execution from start-up through closeout.
• 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.
• Maintain accurate and up-to-date information in the clinical trial management system (CTMS) and monitor clinical trial results posting requirements.
• Schedule and coordinate team meetings, and prepare and file agendas and minutes.
• Assemble study binders, reference manuals, training materials, and Investigator Meeting materials, and distribute materials to study sites.
• Track study closeout 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 information needed to meet study goals.
• Use sound judgment to resolve routine issues and escalate complex matters to appropriate team members.
• Apply company policies, SOPs, and quality and compliance standards, including GCP, ICH, and CFR requirements.
• Communicate clearly, build strong relationships, contribute ideas to improve team processes, and seek new assignments for learning and growth.

Benefits

• Student Loan Paydown program
• Tuition reimbursement
• Family care benefits
• Relocation assistance
• Inclusion, Culture and Well-Being programs, including physical and mental health
• Potential annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits, paid time off, and family support benefits, depending on country and role

What This Job Offers

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