Clinical Trial Associate/Clinical Research Coordinator

Krystal Biotech - Pittsburgh, PA

Full-time - Entry Level

Pittsburgh, PA

Chemical Manufacturing

About the position

The Clinical Trial Associate/Clinical Research Coordinator at Krystal Biotech plays a crucial role in supporting the Clinical Operations Team by managing clinical supplies, ensuring compliance with regulatory practices, and facilitating communication between trial sites and the clinical team. This position involves assisting with multiple clinical trials, conducting data reviews, and adhering to Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines. The role requires travel to clinical sites, particularly during peak periods, to ensure the smooth operation of clinical trials.

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

Requirements

• 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)