Clinical Study Specialist

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Study Specialist to provide technical and administrative support to clinical study teams conducting trials across a program. The role supports studies from site activation through close-out and involves coordinating study activities and collaborating with study leads, CROs, and 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 (e.g., informed consent forms, case report forms) and reference materials (e.g., regulatory, pharmacy, laboratory binders)

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 (e.g., 1572s, financial disclosures) and performs TMF reconciliations with study lead guidance

Communicates with sites as directed, maintaining site contact information and strong relationships internally and externally

Contributes to close-out activities (e.g., 1572s, IP reconciliation, financial disclosures, CRA close-out visits) and supports oversight of third-party vendors as needed

Brings attention to detail, resourcefulness, and proactive problem-solving to assigned study activities, investigating impact on trials as new information arises

Participates in SOP revisions and departmental initiatives, proactively recommending process improvements

Benefits

Primarily on-site with hybrid flexibility

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 (e.g. medical, dental, vision, life and disability), depending on country and role

Paid time off, depending on country and role

Family support benefits, depending on country and role

Company

Develops and commercializes biopharmaceutical medicines for serious diseases

Tarrytown, New York, USA

http://www.regeneron.com/

Founded in 1988

10001+ employees

Qualifications

Bachelor's degree with 2+ years of industry-related work experience in a clinical setting

Ability to acquire 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

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

Required skills

Clinical Drug Development, Medical Terminology, ICH/GCP

Experience

2+ years