Clinical Research Associate

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 Twitter and LinkedIn.

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!

Job Description Summary:

Krystal Biotech, Inc is seeking a highly motivated Clinical Research Associate to coordinate all aspects of the clinical monitoring process. This position ensures that the clinical trial is being conducted according to the approved protocol, amendments and in compliance with Good Clinical Practice (GCP), Company SOPs, and all applicable regulatory requirements.

Specific responsibilities include but are not limited to:

• Serve as a point of contact between investigative sites and the Sponsor.
• Training investigative site staff on protocol responsibilities, Investigational Product accountability and study documentation.
• Establishment of regular lines of communication with sites to manage ongoing study expectations and potential issues.
• Monitor investigative sites according to Good Clinical Practice and applicable regulations – site visits may include, site qualification, initiation, monitoring and close outs.
• Complete applicable visit reports and submit study documentation as appropriate.
• Assist in the development of study documentation including source documents, case reports forms, regulatory binder documents, etc.
• Review investigative site SOPs to confirm the study is well controlled.
• Assurance of regulatory compliance of investigational sites with company SOPs, and ICH guidelines.
• Assist and support development and review of clinical protocols, informed consent forms, or other study-related clinical documents
• 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 continued development of clinical operations SOPs
• Work with accounting/finance to help establish budgets, track invoices, approve vendor activity and reconcile differences
• Other duties as assigned

Experience and Skills Desired:

• BS/BA degree required in science/health-related field
• 2 years of experience in a relevant field supporting clinical trials through a clinical site, CRO or trial sponsor, clinical research coordinator

• Possess good understanding of ICH guidelines, Good Clinical Practices (GCP)
• 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)
• Willing and able to travel