Clinical Study Specialist (Internal Medicine)

Regeneron Pharmaceuticals • Warren, MI

1d • 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, NY, or Warren, NJ, and is primarily on-site with hybrid flexibility.

Requirements

• Bachelor's degree.
• 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 and reference materials.
• Track site activation, enrollment, and monitoring visits against projected plans; escalate issues or delays; and monitor investigator/site status and registry postings.
• Ensure timely receipt of scheduled reports, such as 1572s and financial disclosures, and perform TMF reconciliations with study lead guidance.
• Communicate with sites as directed, maintain site contact information, and support strong internal and external relationships.
• Contribute to close-out activities, including 1572s, IP reconciliation, financial disclosures, and CRA close-out visits; support oversight of third-party vendors as needed.
• Apply attention to detail, resourcefulness, and proactive problem-solving to assigned study activities, investigating the impact of new information on trials.
• Participate in SOP revisions and departmental initiatives, and recommend process improvements.

Benefits

• Competitive and comprehensive total rewards package, which 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: Mid Level