|Department:||Global Clinical Development|
|Job Status:||Full-time, Benefited|
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.
Essential Functions (Include percentage of time after each function):
- 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 Celerion, 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 Celerion preferred