Clinical Study Specialist

About the role

The Clinical Study Specialist plays a crucial role in supporting clinical study teams, ensuring studies proceed smoothly from site activation through close-out. Key responsibilities include organizing and delivering reports, coordinating meetings, tracking progress, and communicating with sites.

Responsibilities

• Organizes and delivers analyzable reports and metrics, and coordinates study team meetings, agendas, and minutes
• Collates data for feasibility and site selection assessments, and contributes to review of study documents and reference materials
• Tracks site activation, enrollment, and monitoring visits against projected plans, escalating issues or delays, and monitors investigator/site status and registry postings
• Ensures timely receipt of scheduled reports, performs TMF reconciliations with study lead guidance, and communicates with sites as directed
• Maintains site contact information and strengthens internal and external relationships, contributing to close-out activities and overseeing third-party vendors as needed
• Bridges attention to detail, resourcefulness, and proactive problem-solving to assigned study activities, investigating impacts as new information arises
• Participates in SOP revisions and departmental initiatives, proactively recommending process improvements

Requirements

• Bachelor's degree with 2+ years of industry-related work experience in a clinical setting
• Working knowledge in trial management systems and MS applications (Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF)
• Basic familiarity with medical terms and clinical drug development
• Awareness of ICH/GCP

Qualifications

• Proactive, self-disciplined, and effective at managing deadlines and priorities

Skills

• Attention to detail
• Resourcefulness
• Proactive problem-solving

Benefits

Regeneron offers a 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
• Insurance benefits (e.g. medical, dental, vision, life and disability)
• Paid time off
• Family support benefits

For additional information about Regeneron benefits in the U.S., please visit here.

Salary Range (annually): $93,900.00 - $153,300.00