Logistics Specialist - United States
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A Logistics Specialist is responsible for the training and tracking of multi-center and/or external clinical site activities in regards to electronic collection tools and specimen management, ensuring compliance to protocol, ICH Good Clinical Practices, Standard Operating Procedure and regulatory and local requirements.
- Work with Clinical Project Managers, Laboratories, Vendors and Sites to identify needed training in areas such as specimen collection, processing and management, topography, spirometry, administration, e-diary, etc.
- Contributes to the study risk assessment in regard this these areas and develops plans for risk mitigation in specimen collection and electronic data collection
- Provides initial training to sites on specialized equipment including tracking access and training records
- Follow-up on study conduct and access additions through the project
- Leads QI and CAPAs for issues involving these tools and processes
- Coordinates transfers of specimens or data between company, multi-sites, laboratories and/or other vendors involved in the project
- Provides updates to the project team
- Develops new training plans, processes and onboarding for new sites, systems, and vendors
- Identify and resolve issues affecting proper conduct of the trial, including escalation to management and other team members as appropriate to ensure proper resolution.
- Perform process audits
- Other duties as assigned
- Bachelor’s degree or equivalent experience preferred*
- Phlebotomy experience preferred
- Highly organized
- Ability to work across multiple projects
- Flexible and willing to travel up to 50%
- Working knowledge of ICH GCP and clinical research regulations
- Proficient computer skills, i.e., MS Word, Excel, Powerpoint, WebEx
- Excellent problem-solving and decision making skills
- Familiarity/experience with company preferred