Clinical Study Specialist (Internal Medicine)

Regeneron Pharmaceuticals • Armonk, NY

2d • $93,900 - $153,300 • Hybrid

About The Position

Regeneron is seeking a Clinical Study Specialist to provide technical and administrative support to clinical study teams executing trials across a program. The role helps keep studies on track from site activation through close-out and collaborates with Clinical Study Leads, Clinical Study Associate Managers, CROs, and study sites. The position is based in Armonk, New York, or Warren, New Jersey, and is primarily on-site with hybrid flexibility.

Requirements

• Bachelor's degree and at least 2 years of industry-related work experience in a clinical setting.
• Ability to acquire working knowledge of trial management systems and Microsoft applications, including Project, PowerPoint, Word, and Excel, as well as IVRS/IWRS, EDC, and TMF.
• Basic familiarity with medical terminology and clinical drug development.
• Awareness of ICH/GCP.
• Proactive and self-disciplined, with the ability to manage deadlines and priorities effectively.

Responsibilities

• Organize and deliver analyzable reports and metrics, and coordinate study team meetings, agendas, and minutes.
• Collate data for feasibility and site selection assessments, and contribute to reviews of study documents, including informed consent forms and case report forms, and reference materials such as regulatory, pharmacy, and laboratory binders.
• Track site activation, enrollment, and monitoring visits against projected plans; escalate issues or delays; and monitor investigator and site status and registry postings.
• Ensure timely receipt of scheduled reports, including 1572s and financial disclosures, and perform Trial Master File (TMF) reconciliations with study lead guidance.
• Communicate with sites as directed, maintain site contact information, and build strong internal and external relationships.
• Contribute to close-out activities, including 1572s, investigational product reconciliation, financial disclosures, and CRA close-out visits, and support oversight of third-party vendors as needed.
• Investigate the impact of new information on trials and bring attention to detail, resourcefulness, and proactive problem-solving to assigned study activities.
• Participate in SOP revisions and departmental initiatives, and proactively recommend process improvements.

Benefits

• Annual bonuses or other incentive plans, depending on country and role.
• Equity awards, depending on country and role.
• Pension or retirement benefits, depending on country and role.
• 401(k) company match, depending on country and role.
• Health and wellness programs, depending on country and role.
• Fitness centers, depending on country and role.
• Insurance benefits, including medical, dental, vision, life, and disability insurance, depending on country and role.
• Paid time off, depending on country and role.
• Family support benefits, depending on country and role.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level