Clinical Trial Associate/Clinical Research Coordinator
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). 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 Associate to support our Clinical Operations Team. The Associate's responsibilities will entail, but not be limited to, assisting with the management and inventory of clinical supplies, ensuring proper materials are available at clinical sites in a timely manner, and working with the Clinical Operations team to support multiple Clinical Trials. Conducting reviews of trial data and follow GCP/ICH protocols/guidelines. Will require travel to Clinical sites, including 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
- Ensure proper documentation and protocol and regulatory practices are being followed
- Establish relationships with and work with trial sites to ensure study materials and documentation are being handled appropriately
- Work with accounting/finance to help establish budgets, track invoices, approve vendor activity and assists with budget reconciliation
- Train investigative site staff on protocol responsibilities, Investigational Product accountability and study documentation
- Monitor investigative sites according to Good Clinical Practice and applicable regulations – site visits may include, site qualification, initiation, monitoring and close outs
- Provides support for inspection readiness by formatting, proofreading documents and contributing to the establishment, maintenance, and quality control of the TMF
- Review investigative site SOPs to confirm the study is well controlled
- Work closely with the investigative sites to ensure understanding of laboratory procedures, study supply availability/accountability and the correct distribution of samples
- Assist in the development of clinical operations SOPs
- Other duties as assigned
Experience and Skills Desired:
- BS/BA degree required in 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
- Ability to travel 25%-50% of the time during peak periods
- 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, while maintaining attention to detail is critical.
- Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities.
- Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and IXRS/EDC platforms)
Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employers. 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.
