Clinical Trial Associate/Clinical Research Coordinator

4 weeks ago


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

Clinical Trial Associate/Clinical Research Coordinator

About Krystal Biotech

Krystal Biotech is a biotechnology company that develops and commercializes genetic medicines to treat diseases with high unmet medical needs. We are seeking a Clinical Trial Associate/Clinical Research Coordinator to support our Clinical Operations Team.

Job Summary

The Clinical Trial Associate/Clinical Research Coordinator will assist with the management and inventory of clinical supplies, ensure proper materials are available at clinical sites in a timely manner, and work with the Clinical Operations team to support multiple Clinical Trials. The successful candidate will have excellent written and oral communication skills, be able to manage multiple priorities, and have a strong understanding of GCP, ICH, and applicable regulatory standards.

Key Responsibilities

  • Assist clinical trial team with preparation, handling, distribution, and tracking of clinical trial supplies and other study supplies
  • Ensure proper documentation and protocol and regulatory practices are being followed
  • Establish relationships with and work with trial sites to ensure study materials and documentation are being handled appropriately
  • Work with accounting/finance to help establish budgets, track invoices, approve vendor activity, and assist with budget reconciliation
  • Train investigative site staff on protocol responsibilities, Investigational Product accountability, and study documentation
  • Monitor investigative sites according to Good Clinical Practice and applicable regulations – site visits may include site qualification, initiation, monitoring, and close outs
  • Provide support for inspection readiness by formatting, proofreading documents, and contributing to the establishment, maintenance, and quality control of the TMF
  • Review investigative site SOPs to confirm the study is well controlled
  • Work closely with the investigative sites to ensure understanding of laboratory procedures, study supply availability/accountability, and the correct distribution of samples
  • Assist in the development of clinical operations SOPs
  • Other duties as assigned

Requirements

  • BS/BA degree required in science/health-related field
  • 1-3 years of experience in a relevant field supporting clinical trials through a clinical site, CRO, or trial sponsor, clinical research coordinator
  • Ability to travel 25%-50% of the time during peak periods
  • Understanding and application of GCP, ICH, and applicable regulatory standards governing clinical research
  • Excellent written and oral communication and presentation skills
  • The ability to manage multiple priorities, while maintaining attention to detail is critical
  • Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities
  • Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and IXRS/EDC platforms)

Krystal Biotech is an Equal Employment Opportunity and Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status.



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