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 Hutchs 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 nations first cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
The position will work directly with an Assistant Member in the Infectious Disease Sciences Program in the Vaccine and Infectious Disease Division to provide support to the PI and research staff in the development, implementation and management of his diverse research portfolio, including research studies and clinical trials.
The Clinical Research Coordinator (CRC) will be responsible for providing support on all aspects of research study and clinical trial development and implementation. Primary responsibilities of the CRC will include assistance with the planning, coordination, implementation, and close-out (e.g. presentation of data, manuscript writing) of industry-sponsored clinical trials, in addition to retrospective and prospective observational or investigator-initiated interventional studies. Additional responsibilities will include communicating with internal and external collaborators and supporting study personnel in the preparation of regulatory documentation and audits if applicable.
Under the supervision of the Research Manager and the PI, the CRC will manage a portfolio of clinical research projects and will be required to perform their responsibilities with a high level of independence within the scope of study protocol(s) and institutional guidelines. The position will include interaction with patients, physicians, researchers, and other clinical providers and support staff within and outside of the Fred Hutch/ Seattle Cancer Care Alliance (SCCA) / UW system including the SCCA Patient Care Services.
Assist the research manager with preparing start-up documentation including IRB documents, eligibility checklists, study procedures/SOPs, study-specific clinic orders and study calendars (if not completed by the Clinical Research Manager)
Screens and registers patients; ensures eligibility requirements are met
Ability to consent patients and assures consent forms are completed correctly and in entirety
Schedules study related clinic procedures such as blood draws, infusions and imaging according to protocol requirements; coordinates with clinic staff to ensure proper documentation and timing of research-related procedures
Perform review of medical charts using ORCA/MINDscape and enter data in REDCap, Excel or other study-related databases
Abstracts data from medical records to complete study-specific case-report form (CRFs) (electronic and/or paper) in timely and accurate manner; maintains shadow chart with source documents
Maintain study and specimen tracking and inventory records for biospecimens pulled from repository.
Assemble study kits for clinical trials.
Perform basic processing and banking of lab specimens and associated record keeping
Collaborates with study sponsor/consortium delegate to assist with study monitoring visits and responds to findings
Creates and maintains patient tracking tools; communicates status to investigators, management and relevant departments
Manages study documentation throughout study life cycle including IRB annual renewals, modifications, patient study charts and regulatory binder
Liaises with study sponsor, investigator(s), research manager and members of study team to communicate timelines, expectations and study status
Acts as a resource to physicians, investigators, other staff members, and other organizations regarding protocol procedures, data collection requirements and other study related operations
Keeps knowledge and skills current by completing mandated training and attending meetings with the study team and the Consortium, such as the monthly coordinator meeting, relevant lectures, faculty and administrative presentations, and other opportunities of interest
Perform other duties as assigned.
Clinical Research Coordinator II Minimum Education/Experience
Bachelors degree in scientific/medical field or equivalent experience/education. Masters degree in healthcare related field is preferred. Minimum of three years post-masters or five years post-bachelors experience in clinical study/trials coordination or related field.
Clinical research related certification is preferred.
Experience with industry-sponsored clinical trials and documentation of case report form (eCRF) in study electronic data capture (EDC) system
Ability to work in teams and independently, flexible hours at times in support of clinical trials and regulatory and related compliance
Strong attention to detail and project management skills and experience is required
Well-organized and ability to juggle numerous tasks, often with conflicting and competing deadlines
Strong written and verbal communication skills
Strong computer skills, including proficiency in the Office Suite, and experience working with excel and databases (preferably REDCap)
Knowledge of federal regulations and guidelines that govern clinical research, including GCP and human subjects research
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At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.