Clinical Trial Monitor / Nurse Educator

Krystal Biotech•Pittsburgh, PA

1d•Onsite

About The Position

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.

Requirements

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).

Responsibilities

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.
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.