Krystal Biotech, Inc. · 5 months ago
Clinical Trial Associate/Clinical Research Coordinator
Pittsburgh, PA
Full-time
Onsite
Entry Level
1+ years expKrystal Biotech, Inc. is a company focused on the discovery and development of genetic medicines. They are seeking a Clinical Trial Associate to support the Clinical Operations Team, which involves managing clinical supplies, ensuring compliance with protocols, and assisting with multiple clinical trials.
BiopharmaBiotechnologyHealth Care
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
Qualification
Required
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)
Company
Krystal Biotech, Inc.
A commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines for high unmet medical needs.
201-500 employees
H1B Sponsorship
Krystal Biotech, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (1)
2021 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$546MKey Investors
Frazier Healthcare PartnersSun Pharmaceutical Industries
2023-05-21Post Ipo Equity· $160M
2021-11-29Post Ipo Equity· $200M
2021-02-02Post Ipo Equity· $100M
Leadership Team
Suma Krishnan
Founder & President
Recent News
GlobeNewswire
2026-01-11
Company data provided by crunchbase