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Location

Santa Monica, CA | United States

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Job description

Santa Monica, CA

Contract Duration: 12-36 months

Rate: Negotiable

Responsibilities:

• Excellent employment opportunity for a Coordinator, Clinical Operations, Logistics in the Santa Monica, CA area.
• Hybrid 3 days a week. 100% remote will be considered.
• 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.
• 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 departments to facilitate the clinical product cell journey
• Arranges meetings, agendas, and minutes
• Travel as needed

Experience:

• 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 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
• Top 3 Required Skill Sets: Logistics background, clinical trial experience, ability to be on call when needed
• Top 3 Nice to Have Skill Sets: Comparator drug sourcing, demand planning, IT experience
  
  
  
  

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Job tags

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Salary