Clinical Trial Associate / Clinical Research Coordinator

About the Company

Krystal Biotech is focused on discovering, developing, manufacturing, and commercializing genetic medicines for diseases with significant unmet medical needs. Established in 2016, the company stands out for its gene therapy science and technology, commercial-scale manufacturing capabilities, and a patient-centered approach to commercialization. It was the first company to secure U.S. FDA approval for a redosable gene therapy, VYJUVEK®, for Dystrophic Epidermolysis Bullosa (DEB). The organization continues to advance a pipeline of investigational genetic medicines across respiratory, oncology, dermatology, and ophthalmology.

Headquartered in Pittsburgh, Pennsylvania, Krystal also operates two CGMP manufacturing facilities there, along with teams in Switzerland, Germany, and Japan. The company describes its culture as one driven by curiosity, courage, scientific rigor, and care.

Role Overview

The Clinical Trial Associate will support the Clinical Operations team in managing multiple clinical studies. This role involves coordinating clinical supplies, making sure study materials reach sites on time, and helping with trial data review in line with GCP and ICH requirements. Travel to clinical sites is expected, and during peak periods it may reach up to 50% of working time.

Key Responsibilities

The position covers a broad mix of clinical operations, site support, documentation control, and vendor coordination.

• Support the clinical trial team with preparation, handling, distribution, and tracking of study and clinical supplies.
• Confirm that required documentation, protocol steps, and regulatory practices are properly followed.
• Build working relationships with trial sites and help ensure materials and records are managed correctly.
• Partner with accounting and finance teams to set budgets, monitor invoices, approve vendor activity, and assist with budget reconciliation.
• Train site staff on protocol duties, investigational product accountability, and study documentation requirements.
• Visit and monitor investigative sites in line with Good Clinical Practice and applicable regulations, including qualification, initiation, routine monitoring, and closeout visits.
• Support inspection readiness by formatting and proofreading documents and helping maintain quality control of the TMF.
• Review site SOPs to verify that the study is being controlled appropriately.
• Coordinate with sites so laboratory procedures, study supply availability, sample accountability, and sample distribution are clearly understood and correctly handled.
• Assist in creating clinical operations SOPs.
• Take on additional tasks as needed.

Requirements

• A BS/BA degree in a science or health-related discipline is required.
• At least 1 to 3 years of relevant experience supporting clinical trials through a site, CRO, sponsor, or as a clinical research coordinator.
• Ability to travel 25% to 50% of the time during peak periods.
• Working knowledge of GCP, ICH, and relevant clinical research regulations.
• Strong written, verbal, and presentation skills.
• Ability to manage several priorities at once while staying highly detail-oriented.
• Skill in organizing work, meeting deadlines, and adapting to changing priorities.
• Strong computer proficiency, including Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and IXRS/EDC systems.

Equal Opportunity and Agency Notice

Krystal Biotech is an Equal Employment Opportunity and Affirmative Action employer. Qualified candidates will be considered without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, marital status, protected veteran status, or disability status. The company does not accept unsolicited resumes from headhunters or agencies submitted through this website or directly to managers, and it will not pay fees to third parties without a signed agreement in place.