Coordinator, Clinical Operations, Logistics
2 weeks ago
Position: Coordinator, Clinical Operations, Logistics Location: Remote Duration: 12 Months Job Type: Contract Work Type: Remote Job Description
- 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 enrolment 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
- 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
- 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
- 2-5 years
- Logistics background, clinical trial experience, ability to be on call when needed
- Comparator drug sourcing, demand planning, IT experience
- Ability to work with our clinical trial sites and manage patients cell journey for treatment.
- College degree preferred
- None at this time
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