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Clinical Study Associate

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 committed to pioneering genetic therapies aimed at fulfilling critical medical requirements. Our dedication to innovation and patient-centric solutions has positioned us at the forefront of gene therapy advancements.

Role Summary:

We are on the lookout for a Clinical Trial Associate to become a vital part of our dedicated team. This role involves assisting in the oversight of clinical supplies, ensuring strict adherence to protocols, and providing support across various Clinical Trials. The 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 study protocols and regulatory requirements
  • 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 obligations and study methodologies
  • Monitor compliance and quality assurance 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 management
  • 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 environments
  • Willingness to travel during peak operational periods
  • Familiarity with Good Clinical Practice (GCP), International Council for Harmonisation (ICH), and regulatory guidelines
  • 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.