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Clinical Trial Coordinator

2 months ago

Pittsburgh, Pennsylvania, United States Krystal Biotech Full time
Job Overview

Position: Clinical Trial Associate/Clinical Research Coordinator

About Krystal Biotech:

Krystal Biotech is a leading organization focused on pioneering genetic therapies aimed at fulfilling unmet medical demands. Our commitment to innovation and patient-centered care has propelled us to the forefront of gene therapy advancements.

Role Summary:

We are in search of a Clinical Trial Associate to become an integral part of our dedicated team. The selected candidate will play a crucial role in managing clinical supplies, ensuring adherence to established protocols, and supporting various Clinical Trials. This position may require travel to clinical sites, especially during high-demand periods.

Key Responsibilities:

  • Assist in the preparation, management, and tracking of clinical trial materials
  • Ensure compliance with protocols and regulatory guidelines
  • Build and maintain relationships with trial sites while overseeing study documentation
  • Collaborate with the finance team to manage budgets and financial documentation
  • Provide training to site personnel on protocol requirements and study methodologies
  • Monitor compliance and uphold quality standards at trial sites
  • Support the maintenance of trial-related documentation
  • Review site Standard Operating Procedures (SOPs) to ensure study integrity
  • Work closely with sites regarding laboratory processes and sample handling
  • Contribute to the development of clinical operations SOPs

Qualifications and Skills:

  • Bachelor's degree in a science or health-related discipline
  • 1-3 years of experience in clinical trial settings
  • Willingness to travel during peak operational periods
  • Familiarity with Good Clinical Practice (GCP), International Council for Harmonisation (ICH), and regulatory requirements
  • Excellent communication and organizational abilities
  • Proficient in Microsoft Office Suite and Electronic Data Capture (EDC) systems

Krystal Biotech is an equal opportunity employer dedicated to fostering diversity within the workplace.