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Clinical Research Associate
2 months ago
Position: Clinical Trial Associate/Clinical Research Coordinator
About Krystal Biotech:
At Krystal Biotech, we unite passionate individuals dedicated to the discovery, development, and commercialization of innovative genetic therapies aimed at addressing significant medical needs. Our foundation in 2016 has set us apart through our cutting-edge gene therapy platform, advanced manufacturing capabilities, and a unique approach to commercialization that prioritizes patient experience.
We are proud to have received FDA approval for VYJUVEK, the first and only redosable gene therapy for Dystrophic Epidermolysis Bullosa (DEB). Our proprietary platform continues to drive a promising pipeline of investigational genetic therapies across various fields, including respiratory, oncology, dermatology, and ophthalmology.
Headquartered in Pittsburgh, PA, we operate two state-of-the-art CGMP manufacturing facilities and maintain teams worldwide, with additional offices in Switzerland, Germany, and Japan. Our culture is built on values of care, courage, and scientific integrity, and we are looking for individuals who embody these principles.
Role Summary:
Krystal Biotech, Inc. is in search of a Clinical Trial Associate to assist our Clinical Operations Team. The Associate will be responsible for managing clinical supplies, ensuring timely availability of materials at clinical sites, and collaborating with the Clinical Operations team to support various Clinical Trials. This role involves reviewing trial data and adhering to GCP/ICH protocols and guidelines. The position may require travel to clinical sites, potentially up to 50% during peak periods.
Key Responsibilities:
- Support the clinical trial team in the preparation, management, distribution, and tracking of clinical trial materials and supplies.
- Ensure compliance with documentation, protocols, and regulatory practices.
- Establish and maintain relationships with trial sites to guarantee proper handling of study materials and documentation.
- Collaborate with finance to develop budgets, track invoices, approve vendor activities, and assist with budget reconciliation.
- Provide training to investigative site staff on protocol responsibilities, accountability for Investigational Products, and study documentation.
- Monitor investigative sites in accordance with Good Clinical Practice and relevant regulations, including site qualification, initiation, monitoring, and close-out visits.
- Assist in maintaining inspection readiness by formatting and proofreading documents and contributing to the quality control of the Trial Master File (TMF).
- Review site-specific SOPs to ensure effective study control.
- Work closely with investigative sites to clarify laboratory procedures, availability of study supplies, and proper sample distribution.
- Contribute to the development of clinical operations SOPs.
- Perform other related duties as assigned.
Qualifications and Skills:
- Bachelor's degree in a science or health-related field is required.
- 1-3 years of relevant experience supporting clinical trials at a clinical site, CRO, or trial sponsor.
- Willingness to travel 25%-50% during peak periods.
- Familiarity with GCP, ICH, and applicable regulatory standards governing clinical research.
- Strong written and verbal communication skills, along with effective presentation abilities.
- Ability to manage multiple priorities while maintaining attention to detail.
- Proficient in Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and IXRS/EDC platforms.
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 identity, national origin, age, marital status, protected veteran status, or disability status.
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