Clinical Study Assistant

Regeneron is currently looking for a Clinical Study Assistant to join our Clinical Sciences team. Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases. In this role, you will support the clinical study team in the initiation, maintenance, and closeout of clinical trials across all phases, helping keep studies compliant, organized, and on track for patients worldwide.

When & where:

• Location: Armonk, NY, Warren, NJ
• Work model: Primarily on-site with hybrid flexibility
• Travel: Up to 25% travel may be required

What you’ll do:

• 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 escalate 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

Let’s find out if we’re a fit:

• 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, and familiarity with medical terminology
• Proficiency with Microsoft Office, including Excel and PowerPoint
• Strong time management, attention to detail, and written and verbal communication skills

Thrive today. Grow tomorrow.

• Student Loan Paydown program & Tuition Reimbursement*
• Family Care Benefits
• Relocation Assistance
• Inclusion, Culture and Well-Being programs (including physical & mental health)

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (hourly)