Clinical Trial Associate/Clinical Research Coordinator

About Krystal Bio

Krystal Biotech brings together brilliant minds to develop genetic medicines for diseases with high unmet medical needs. Founded in 2016, Krystal is distinguished by its patented gene therapy platform, advanced manufacturing capabilities, and a patient-centric commercialization model. Krystal received FDA approval for VYJUVEK, the first and only redosable gene therapy for Dystrophic Epidermolysis Bullosa. The company continues to advance a pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology. Based in Pittsburgh, Krystal operates two state-of-the-art CGMP facilities and has offices globally.

Job Description Summary

Krystal Biotech, Inc. seeks a Clinical Trial Associate to support the Clinical Operations Team. Key responsibilities include managing and tracking clinical supplies, ensuring compliance with protocols and regulations, and supporting multiple clinical trials. The role requires travel to clinical sites, up to 50% of the time, during peak periods.

Primary Responsibilities

• Assists clinical trial team with preparation, handling, distribution, and tracking of clinical trial supplies and other study supplies
• Ensures proper documentation and protocol and regulatory practices are being followed
• Establishes relationships with and works with trial sites to ensure study materials and documentation are handled appropriately
• Works with accounting/finance to help establish budgets, track invoices, approve vendor activity, and assists with budget reconciliation
• Trains investigative site staff on protocol responsibilities, Investigational Product accountability, and study documentation
• Maintains oversight of investigative sites according to Good Clinical Practice and applicable regulations – site visits may include, site qualification, initiation, monitoring, and close-outs
• Supports inspection readiness by formatting, proofreading documents, and contributing to the establishment, maintenance, and quality control of the TMF
• Reviews investigative site SOPs to confirm the study is well-controlled
• Works closely with investigative sites to ensure understanding of laboratory procedures, study supply availability/accountability, and correct distribution of samples
• Aids in the development of clinical operations SOPs
• Performs other duties as assigned

Experience and Skills Desired

• BS/BA degree in a 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
• 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, maintain attention to detail, prioritize tasks, meet deadlines, and be flexible to changing priorities
• Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and IXRS/EDC platforms)

Equal Employment Opportunity

Krystal Biotech, Inc. 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. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.