Regeneron
Regeneron
Regeneron este o companie de biotehnologie care descoperă, dezvoltă și comercializează medicamente pentru afecțiuni grave și insuficient deservite. Cercetările sale acoperă alergiile, bolile cardiovasculare și metabolice, neuroștiința, oncologia, hematologia, oftalmologia și bolile rare. Prin combinarea cercetării biologice cu tehnologia avansată, Regeneron dezvoltă medicamente biologice și genetice concepute pentru a răspunde unor nevoi complexe de sănătate. Compania pune, de asemenea, accent pe echitatea în sănătate, responsabilitatea față de mediu, educația științifică și practicile corporative etice, ca parte a misiunii sale mai ample de a îmbunătăți îngrijirea pacienților.

Clinical Study Specialist at Regeneron

Support Regeneron clinical trial teams by coordinating study data, sites, reporting, and close-out activities. Help keep studies on track from site activation through completion.

Descriere

  • Support clinical study teams with technical and administrative work across trial programs.
  • Help keep studies on schedule from site activation through close-out.
  • Prepare reports and metrics in formats suitable for analysis.
  • Coordinate study team meetings, including agendas and minutes.
  • Compile information for feasibility reviews and site selection.
  • Assist with reviewing study documents and reference materials.
  • Monitor site activation, enrollment, and monitoring visits against plans.
  • Raise issues and delays, and track investigator and site status as well as registry postings.
  • Follow up on scheduled reports and reconcile trial master files with guidance from the study lead.
  • Contact sites as directed and maintain site details and working relationships.
  • Assist with study close-out and support oversight of external vendors.
  • Assess how new information may affect ongoing trials.
  • Take part in standard operating procedure updates and departmental initiatives.
  • Suggest ways to improve processes.

Cerințe

  • Bachelor’s degree and at least two years of industry-related clinical experience.
  • Ability to develop 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.

Beneficii

  • Annual bonuses or other incentive plans.
  • Equity awards.
  • Pension or retirement benefits.
  • 401(k) plan with company match.
  • Health and wellness programs.
  • Fitness centers.
  • Medical, dental, vision, life, and disability insurance.
  • Paid time off.
  • Family support benefits.
  • Reasonable accommodations during recruitment where required.

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