Gilead Sciences, Inc. Logistics Coordinator in Stockley Park, United Kingdom
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job
Kite Pharma is a biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies. We are on a rapid growth trajectory and have a highly energized and accomplished team.
The Clinical Logistics Coordinator is an in-house sponsor position who will oversee multiple logistical aspects of clinical trial conduct including study start-up, enrollment of study participants, tracking of samples, scheduling of patient care all leading up to treatment with investigational product. The candidate must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, as well logistics. The position will report to the Senior Director of Clinical Operations.
Responsibilities (include but, are not limited to):
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
Must be willing to travel at least 20% (possibly more)
Working knowledge of transplant patient care and apheresis collection 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 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
Kite is a biopharmaceutical 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. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com . Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma .
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community at http://gilead.avature.net/Gilead