Clinical Trials Specialist - Clinical Operations
Clinical Development | Santa Monica, CA | Full Time
Kite Pharma, Inc. is focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to eradicate cancer cells. We believe our immunotherapy is a market-redefining approach to the treatment of cancer. We are an innovative and growing company located in beautiful Santa Monica and have a highly energized and accomplished team. We had one of the most successful biotechnology IPOs in 2014 and have a current market capitalization of well over $2 billion (NASDAQ: KITE).
The Clinical Trials Specialist is an in-house sponsor position who will oversee multiple 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. 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 communicate with research staff to schedule and coordinate the 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 identify 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)
- Prepare and submit 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 provide 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
- Other duties as assigned
- At minimum, a bachelor’s degree in nursing, science or health related field required
- Four or more years of experience with at least 2 years of related oncology clinical trial coordinating experience
- Must be willing to travel at least 25% (possibly more)
- Working knowledge of transplant patient care and apheresis collection a plus
- Ability to deal with time demands, incomplete information or unexpected events
- 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 Pharma, an equal opportunity employer, is located in beautiful Santa Monica, CA just steps from Santa Monica Blvd and right off the 10. We are able to offer the opportunity to be part of the first 200 employees in 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. Did we forget to mention the stock options? To learn more about us, please visit our website at www.kitepharma.com.
If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.