Description

Clinical Trial Monitor / Nurse Educator

About Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs.

Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient’s end-to-end experience.

Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK®, for the treatment of Dystrophic Epidermolysis Bullosa (DEB), an ultra-rare disease. Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology.

Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values.

Job Description Summary:

Krystal Biotech, Inc. is seeking a Clinical Trial Monitor / Nurse Educator to join our Clinical Operations team. This dynamic role is primarily focused on clinical trial monitoring (~75%), ensuring site compliance, data integrity, and GCP adherence across our investigational programs. The remaining scope (~25%) involves clinical education — supporting healthcare professionals, patients, and caregivers as a subject matter expert on our rare disease treatments.

This position is based in our Pittsburgh office with regular field travel required to support clinical site monitoring activities.

Primary Responsibilities:

Clinical Trial Monitoring (~75%)

Conduct routine and for-cause site monitoring visits (SMVs) at clinical sites, including site initiation, interim monitoring, and closeout visits, in accordance with ICH GCP guidelines, applicable regulations, and sponsor SOPs.
Review and verify the accuracy and completeness of Case Report Forms (CRFs) against source documents; identify and resolve data discrepancies and protocol deviations.
Assess site compliance with the clinical protocol, IND regulations, and applicable local/federal requirements; escalate compliance concerns appropriately.
Establish and maintain strong, productive relationships with Principal Investigators, site coordinators, and clinical staff at assigned sites.
Author detailed site visit reports (SVRs), follow-up letters, and deviation/issue logs in a timely and accurate manner within the CTMS.
Oversee investigational product (IP) accountability, storage conditions, and chain-of-custody at clinical sites.
Support site activation activities including regulatory document collection, IRB/IEC submissions tracking, and essential document file maintenance.
Collaborate cross-functionally with Clinical Operations, Data Management, Regulatory Affairs, and Pharmacovigilance to resolve site-level issues and support overall trial execution.
Contribute to the development and review of monitoring plans, site-specific training materials, and protocol-related training.

Clinical Education (~25%)

Deliver expert training on a pre-approved curriculum to various audiences, including healthcare professionals, field personnel, patients, caregivers, and office staff.
Serve as a primary point of contact for field nurses and clinical staff, fielding and responding to treatment-related inquiries as a subject matter expert and escalating when necessary.
Develop resource materials and communication plans to help healthcare professionals and families understand therapy procedures, potential outcomes, and ongoing care requirements.
Create and maintain a clinical repository with rigorous documentation practices; collaborate with internal teams to integrate new findings into training materials and clinical practice.
Provide comprehensive education on prescribed gene therapy products and recommend resources for patients and caregivers.

Requirements and Desired Qualifications:

Bachelor of Science in Nursing (BSN) preferred, or RN with equivalent experience.
Clinical monitoring experience (CRA or equivalent), preferably within biotech, pharma, or a CRO environment; rare disease or gene therapy experience a plus.
Active RN licensure preferred; clinical nursing background (particularly pediatrics) strongly valued.
Working knowledge of ICH GCP guidelines, FDA regulations and data integrity principles.
Experience with CTMS platforms, EDC/eCRF systems (e.g., Medidata Rave, Veeva Vault), and eTMF management is a plus.
Excellent computer skills (Microsoft Office Suite — Word, Excel, PowerPoint, Outlook, Project).
Strong written and verbal communication skills; ability to author clear, concise monitoring visit reports and correspondence.
Demonstrated ability to collaborate with cross-functional partners and key stakeholders to deliver an optimized patient and site experience.
Ability to manage multiple priorities while maintaining meticulous attention to detail.
Ability to travel as required (25–50% during peak periods).

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. does not accept unsolicited headhunter and agency resumes. 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.

Clinical Trial Monitor / Nurse Educator

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