Clinical Trial Associate/Clinical Research Coordinator

About Krystal Bio:

At Krystal Biotech, Inc., we bring together the brightest and most eager minds to relentlessly pursue the discovery, development and delivery of transformative medicines for people with serious and life-threatening genetic diseases. Founded in 2016, the Company is the leader in redosable gene therapy with prominent clinical and pre-clinical stage programs for dystrophic epidermolysis bullosa, TGM1-deficient ARCI, Netherton Syndrome, Cystic Fibrosis, alpha-1 antitrypsin deficiency, and is advancing research to apply our technology to these and other diseases. The Company’s innovation is fueled by visionary leadership within an entrepreneurial organizational structure with a robust pipeline of investigational medicine.

Our US headquarters is in Pittsburgh, PA with other offices located in Boston, MA and in Zug, Switzerland. For more information about the Company’s platform, commitment to patients and pipeline, please visit http://www.krystalbio.com and engage with us on and .

We have an exciting journey ahead and a tremendous opportunity for growth, and now is the time to make a meaningful impact on the lives of our patients!

Summary:

Krystal Biotech, Inc. is seeking a Clinical Trial Associate to support our Clinical Operations Team. The Clinical Trial Associate's responsibilities will entail but not be limited to assisting in 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.

Specific responsibilities include but are not limited to:

• Work closely with the investigative sites to ensure understanding of laboratory procedures, study supply availability/accountability and the correct distribution of samples
• Train investigative site staff on protocol responsibilities, Investigational Product accountability and study documentation
• Work with accounting/finance to help establish budgets, track invoices, approve vendor activity and assists with budget reconciliation
• Provides support for inspection readiness by formatting, proofreading documents and contributing to the establishment, maintenance, and quality control of the TMF
• Assists clinical trial team with preparation, handling, distribution and tracking of clinical trial supplies and other study supplies
• Other duties as assigned
• Review investigative site SOPs to confirm the study is well controlled
• Ensure proper documentation and protocol and regulatory practices are being followed
• Assist in the development of clinical operations SOPs
• Establish relationships with and work with trial sites to ensure study materials and documentation are being handled appropriately
• Monitor investigative sites according to Good Clinical Practice and applicable regulations – site visits may include, site qualification, initiation, monitoring and close outs

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
• Excellent written and oral communication and presentation skills
• The ability to manage multiple priorities, while maintaining attention to detail is critical.
• Ability to travel 25%-50% of the time during peak periods
• Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities.
• Understanding and application of GCP, ICH, and applicable regulatory standards governing clinical research
• Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and IXRS/EDC platforms)

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