Clinical Trial Associate/Clinical Research Coordinator

Krystal Biotech•Pittsburgh, PA

35d

About The Position

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.

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)

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