Clinical Trial Operations Specialist

Regeneron Pharmaceuticals, Inc.; Kentucky; On-site; USD 70,000 - 95,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Study Specialist to join its Clinical Trial Management team.

You will provide technical and administrative support across trials from site activation through close-out, collaborating with trial leads, CROs, and study sites. The role requires a Bachelor's degree with 2+ years in a clinical setting, familiarity with trial management systems and MS Office, and knowledge of ICH/GCP.

Qualifications

• Bachelor's degree in a related field with 2+ years of industry experience in a clinical setting.
• Familiarity with trial management systems and MS applications (PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF).
• Knowledge of ICH/GCP and clinical drug development terms.

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.

Skills

Clinical study experience

Trial management

MS Office proficiency

ICH/GCP knowledge

Deadline management

Education

Bachelor's degree

Tools

PowerPoint

Word

Excel

IVRS/IWRS

EDC

TMF

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Study Specialist to join its Clinical Trial Management team.

You will provide technical and administrative support across trials from site activation through close-out, collaborating with trial leads, CROs, and study sites. The role requires a Bachelor's degree with 2+ years in a clinical setting, familiarity with trial management systems and MS Office, and knowledge of ICH/GCP.