Coordinator, Clinical Logistics

仕事内容

The Clinical Logistics Coordinator is responsible for investigational product cell journey logistics, chain of custody, and chain of identity In so doing, this role collaborates with several cross functional stakeholders, including clinical trial personnel, Clinical Operations, Data Management, Clinical Development, Medical Affairs, Regulatory Affairs, Technical Operations, Manufacturing, MSAT, and Quality. This role is a part of the study management team and reports to the Clinical Operations Logistics Manager.

Responsibilities (include but are not limited to):

• Arranges product cell journey logistics: all transport legs, customs, courier, and broker interactions

• Communicates study enrollment requirements pertaining to the cell journey

• Contributing member of Clinical Trial study teams

• Drives the cell journey for assigned primary and backup studies

• Engages Contract Research Organizations to facilitate the cell journey

• Interacts with investigational site medical personnel

• Maintains product chain of identity and chain of custody

• Participates in 24/7 on-call response program

• Provides training at study trial meetings as needed

• Tracks and prepares cell journey information utilizing databases, spreadsheets, and other tools

• Utilizes vendor/supplier systems to place relevant orders

• Works cross-functionally with Technical Operations, Manufacturing, Quality and other depts to facilitate the clinical product cell journey

• Arranges meetings, agendas, and minutes

• Travel as needed

• Other duties as assigned

Basic Qualifications:

• 4+ years of relevant clinical or logistics experience

• 2+ years of relevant clinical or logistics experience with a BS/BA

• 0 years of relevant clinical or logistics experience with a MS/MA

Preferred Qualifications:

• Detail oriented

• Able to work independently and as part of a team

• Excellent verbal and written communication

• Experience with Agile change control management a plus

• Experience with courier services

• Experience with cold chain logistics

• Experience with CRM systems: Salesforce, Oracle, SAP a plus

• Experience with ERP systems: Oracle, SAP a plus

• Familiar with domestic and international logistics/transport of biologic material (IATA, ICAO, ADR, DOT, WHO).

• Knowledge of biological tissue transportation and logistics

• Organized, prioritizes workload, and manages time well

• Understands basic FDA & EMA regulations, ICH guidelines, and GCP

• Understands basic patient care, treatment scheduling, and management

• Proficient with Microsoft Word, PowerPoint, and Excel