Logistics Coordinator - Pharma - United Kingdom
- Our company is a bio pharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
- The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
- Our company is currently adding additional talent as it focuses on developing the European Region in support of providing maximum access to patients with unmet needs.
- Serves as a primary liaison and clinical trial resource for the screening and enrollment of clinical trial participants across multiple clinical studies
- Proactively communicates with site research staff, vendors, and manufacturing to schedule and coordinate the “cell journey” activities as well as initiation/completion of study treatment and subsequent patient visits
- Coordinates all aspects of study participant sample collection and “cell journey” including apheresis, shipping, processing, manufacturing and return of investigational product back to the clinical trial sites
- Communicates protocol requirements while ensuring adherence to the cell journey process
- Continuously refines and improves the cell journey process including the screening/enrollment of trial patients, patient scheduling and treatment process
- Prepares metrics and updates for management as assigned. Proactively identifies potential study issues/risks and recommends/implements solutions
- Prepares and/or reviews study-related or essential study start-up documents as they relate to the supported clinical trials (e.g., protocols Informed consent forms, Clinical Site Procedures Manual, Pharmacy Manual, and standard operating procedures)
- Prepares and submits IRB/EC application until final approval received (initial submission /Amendments)
- Works with multiple contract research organizations to communicate detailed timelines and ensure that performance expectations are met
- Attends internal team meetings, and provides training as necessary at investigator meetings and other trial-specific meetings
- Reviews site study documents (informed consent template and study tools/worksheets)
- Participates in the development, review and implementation of departmental SOPs and processes
- At minimum, a bachelor’s degree in nursing, science or health related field required
- Working knowledge of transplant patient care and apheresis collection is a plus
- Ability to deal with time demands or unexpected events as they relate to patient scheduling and the shipping of research materials
- Ability to work with multiple database and electronic systems. Experience with Clinical Trial Management System (CTMS), courier, and material ordering portals, considered a plus
- Must display strong analytical and problem solving skills. Attention to detail required
- Outstanding organizational skills with the ability to multi-task and prioritize
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Must be willing to travel at least 25%
- Our company is an equal opportunity employer.
- We are able to offer the opportunity to be part of this successful, fast growing company.
- A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.