Clinical Trial Support Specialist

BioSpace; Armonk (NY); Híbrido; USD 47.000 - 77.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Student Loan Paydown program

Tuition Reimbursement

Relocation Assistance

Inclusion, Culture and Well-Being

Descripción de la vacante

Regeneron is seeking a Clinical Study Assistant to join the Clinical Sciences team in Armonk, NY. You will support the initiation, maintenance, and closeout of clinical trials across all phases, ensuring studies stay compliant, organized, and on track for patients worldwide.

Location: Armonk, NY, Warren, NJ; Work model: primarily on-site with hybrid flexibility; Travel up to 25%. The role requires 0–1 year of relevant experience and a life sciences or nursing background.

Formación

• BS/BA in life science or nursing preferred; 0-1 year of relevant experience.
• General understanding of clinical research process and regulations/guidelines.
• Familiarity with medical terminology.
• Proficiency with Microsoft Office, including Excel and PowerPoint.

Responsabilidades

• Support the Clinical Study Lead and study team with all aspects of study execution, from start-up through close-out.
• Collect, review, and track site regulatory documents and start-up activities using established study tools.
• Review, maintain, and QC essential study documents in the eTMF according to the TMF plan.
• Keep CTMS accurate and up to date, and monitor posting requirements.
• Schedule and coordinate team meetings, and prepare and file agendas and minutes.
• Assemble study binders, reference manuals, and training materials, and distribute to study sites.
• Track study close-out activities, including FDA Form 1572s, product reconciliation, and financial disclosures.
• Support submissions to internal review committees, consulting agreements, study-level financial requisitions, and Apostille/notary of trial documents.
• Partner with internal departments to exchange information to meet study goals.
• Use sound judgment to resolve routine issues and elevate complex matters to the right team members.
• Work accurately and stay organized while multitasking in a fast-paced setting where priorities shift.
• Learn and apply company policies, SOPs, and quality/compliance standards (GCP, ICH, CFR).
• Communicate clearly, build relationships, and contribute ideas to improve team work.
• Seek out new assignments to learn and grow.

Conocimientos

Time management

Attention to detail

Written & verbal communication

Medical terminology familiarity

Team collaboration

Educación

BS/BA in life science or nursing degree

Herramientas

Microsoft Excel

Microsoft PowerPoint

Descripción del empleo

Regeneron is seeking a Clinical Study Assistant to join the Clinical Sciences team in Armonk, NY. You will support the initiation, maintenance, and closeout of clinical trials across all phases, ensuring studies stay compliant, organized, and on track for patients worldwide.

Location: Armonk, NY, Warren, NJ; Work model: primarily on-site with hybrid flexibility; Travel up to 25%. The role requires 0–1 year of relevant experience and a life sciences or nursing background.