Cures Start Here.
At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first and largest cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network.
Careers Start Here.
The position will work directly with hospital, clinic and research staff in the development, implementation, management, and close-out of interventional Phase I-II clinical trials for hematopoietic cell transplantation with a focus on graft versus host disease.
Responsible for Investigational New Drug submissions, Institutional Review Board documentation, screening patients for eligibility, tracking patient visits, coordinating clinic procedures, and the collection, abstracting, reporting, and quality control of clinical trial data in accordance with protocols subject to FDA oversight. Responsible for coordination of multi-site studies and the long-term follow-up activities associated with these protocols. Serve as a resource to other investigative trial sites to accomplish study goals.
- The Coordinator will work on multiple studies under the supervision of the Principal Investigator in Clinical Transplant Research and will report regularly to the PI on the progress of the studies. Uses judgment in data collection, quality control, liaison, and research coordination activities. Interacts with patients, physicians, and other clinical providers and support staff within and outside of the FHCRC/SCCA/UW system including the SCCA Transplant Service.
- Prepares study start-up documentation including FDA submissions, IRB documents, eligibility checklists, study-specific clinic orders and study calendars.
- Research, maintain, analyze, and abstract patient clinical trial data from pre-study background (e.g., previous diagnoses and treatments) through clinical trial participation and long-term follow-up.
- Ensures patient eligibility requirements for clinical trials are met, assists in patient enrollment, screens and registers patients on study.
- Understand and interact with departments and automated electronic medical record systems throughout FHCRC/SCCA/UW system to ensure timely and complete delivery of data.
- Track status of potential and active clinical trial participants.
- Create and maintain the study's manual of operations and laboratory manual.
- Create and maintain a RedCap database or equivalent for collection of study data. Abstracts data from medical records to complete study-specfic case report forms. Maintains shadow chart with source documents. Assists in the development of data acquisition forms and instructions for completion.
- Schedules study related clinic procedures such as blood draws, infusions and treatment according to protocol requirements; coordinates with clinic staff to ensure proper documentation and timing of research-related procedures.
- Coordinate and support regularly scheduled Sponsor or institutional monitoring visits to ensure quality and completeness of data. Responds to all findings and implements corrective action as necessary.
- Coordinate long-term follow-up evaluations and data collection with clinical trial participants, SCCA, and participants' local physicians.
- Serve as a liaison and reference resource to Physicians, Investigators, other staff members, and other organizations with questions about data collection or protocol procedures and requirements.
- Coordinate special projects regarding data collection, analysis, output, and presentation.
- Ensures compliance with ongoing reporting requirements to the Food and Drug Administration, National Institutes of Health, Human Subjects Committee, Institutional Review Board, Pharmaceutical Companies, and other agencies, to include initial protocol/IND submissions, annual reports, study amendments, safety reports, and unanticipated problem/noncompliance reports. Serves as primary liaison to regulatory bodies.
- Coordinate submission of new investigator-sponsored IND applications to the FDA, and draft non-technical portions of IND applications. Support development, review, and maintenance of protocol-specific and IND-specific documents and procedures.
- BA/BS in a life sciences field of study required.
- Applicant must have one to two years of research or related experience.
- Previous experience in oncology research and clinical data collection is preferred.
- This position requires excellent organizational skills, attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment.
- Collaborative focus is essential, as well as strong written and verbal communication skills, including computer skills.
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