Clinical Trial Associate/Clinical Research Coordinator

Thanks for visiting our Career Page. Please review and apply to our positions which match your qualifications.Krystal Biotech, a Pittsburgh-based company founded in 2016, has quickly emerged as a global leader in gene therapy.

In May 2023, Krystal Bio received FDA approval for the first-ever redosable gene therapy, VYJUVEK™, for the treatment of Dystrophic Epidermolysis Bullosa. Krystal continues to leverage their proprietary platform to develop new treatments throughout its clinical pipeline.

Additionally, the company has developed innovative commercial- and clinical-stage manufacturing processes, deployed across two state-of-the-art GMP facilities.BenefitsWe make every effort to provide essential and desirable benefits that make each employee's life that much easier. In addition to benefits listed below, we also offer competitive compensation that rewards you for your contributions toward achieving company goals.Benefits include:Equity / Stock OptionsMedical and Prescription Drug CoverageDental and Vision InsuranceShort and Long-Term Disability Insurance401(k) With Company MatchPaid HolidaysPaid Time OffFlexible Spending Accounts (Health Care & Dependent Care)Employee Assistance Program & Benefits Concierge AppAD&D and Life InsuranceWellness Rewards ProgramClinical Trial Associate/Clinical Research CoordinatorPittsburgh, PAFull TimeClinical OperationsMid LevelShareClinical Trial Associate/Clinical Research CoordinatorAbout 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 suppliesEnsure proper documentation and protocol and regulatory practices are being followedEstablish relationships with and work with trial sites to ensure study materials and documentation are being handled appropriatelyWork with accounting/finance to help establish budgets, track invoices, approve vendor activity and assists with budget reconciliationTrain investigative site staff on protocol responsibilities, Investigational Product accountability and study documentationMonitor investigative sites according to Good Clinical Practice and applicable regulations – site visits may include, site qualification, initiation, monitoring and close outsProvides support for inspection readiness by formatting, proofreading documents and contributing to the establishment, maintenance, and quality control of the TMFReview investigative site SOPs to confirm the study is well controlledWork closely with the investigative sites to ensure understanding of laboratory procedures, study supply availability/accountability and the correct distribution of samplesAssist in the development of clinical operations SOPsOther duties as assignedExperience 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 coordinatorAbility to travel 25%-50% of the time during peak periodsUnderstanding and application of GCP, ICH, and applicable regulatory standards governing clinical researchExcellent written and oral communication and presentation skillsThe 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 anEqual 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.ShareApplyApply for this positionRequired*First Name*Last Name*Email Address*Phone*AddressResume*We've received your resume.

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This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated.Learn more.GenderDecline to answerFemaleMaleRace/EthnicityDecline to answerHispanic or LatinoWhite, not Hispanic or LatinoBlack or African-American, not Hispanic or LatinoAsian, not Hispanic or LatinoNative Hawaiian or Other Pacific Islander, not Hispanic or LatinoAmerican Indian or Alaskan Native, not Hispanic or LatinoTwo or More Races, not Hispanic or LatinoMENA (Middle Eastern and North African)Human Check*Submit Application