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 Seattle Vaccine Trials Unit (VTU) ( click here to visit their webpage ) is a program within the Vaccine & Infectious Disease Division of Fred Hutchinson Cancer Research Center. Led by Principal Investigator Julie McElrath, the VTU is funded to conduct phase I, II, and III clinical trials. As a clinical research site, the VTU is responsible for the recruitment, selection, and enrollment of study participants, and immunization and clinical monitoring of these participants in clinical trials of investigational agents being studied for the prevention of HIV, SARS-CoV-2, and other infectious diseases.
The Data Coordinator Lead coordinates clinical research data collection processes and data quality management in support of the Seattle Vaccine Trials Unit. The position is responsible for assuring adherence to protocol-required data collection ongoing data quality control, as well as overall data quality assurance and quality management. The role will also be responsible for developing processes, procedures, and administrative materials, carrying-out moderately complex research assignments, and assisting in study implementation.
The Data Coordinator Lead works under the direction of the Clinic Coordinator, referring project/study issues on and/or soliciting guidance as necessary. Special skills and knowledge are applied in coordinating clinical research data collection and associated tracking and quality management activities. May coordinate the work of other project/study staff, including data entry and other administrative personnel.
Enter, submit, review and/or monitor clinical trial datautilizing both paper and electronic source documentation, and multiple electronic data capture systems (REDCap, Medidata Rave,eClinical, and other sponsor-specific systems)
Perform ongoing data quality control and routine data quality assurance to ensure quality and completeness of data submitted
Serve as a liaison and reference resource for protocol investigators and other staff members regarding data collection requirements.This will include serving as a subject matter expert for other unit staff in the use of all relevant EDC systems
Monitor adherence to protocol data collection requirements, investigating any deviation or violation
Coordinate data quality assurance activities
Maintain ongoing contact with clinicians and others collecting data to ensure timely and complete reporting
Assist the Clinic Coordinator in assessing overall data system functions and procedures for the unit
Aid in the design, development and testing of programs and procedures relating to data collection, processing, entry, and quality control
Prepare special reports and analyses for use in assessing protocol-specific or broader unit activities
Assist in the establishment of timetables for data collection and processing tasks
Supervise the training of new administrative staff and clinicians on data systems for each protocol.
Create and maintain tools to assist in the collection, storage, and retrieval of data by maintaining records of all participant files for all protocols conducted by the unit
In conjunction with the Clinic Coordinator, manage development of, and updates to, protocol-specific source documentation and protocol-specific charts for screening, enrollment, and follow-up of research participants.
Ensure all signed informed consent forms are maintained and tracked.
Maintain training in Health Insurance Portability and Accountability (HIPAA), Blood-Borne Pathogens (BBP), Human Subjects Protection (HSP), and Good Clinical Practices (GCP).
Bachelor's Degree or two-year degree in the life sciences or medical field with applicable experience required
Two years' experience in data management and/or project coordination in a clinical trials or clinical research setting required
Experience working with electronic data systems, particularly clinical trial databases such asREDcappreferred
Strong computer skills and excellent written and verbal communication skills required
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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.