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 Clinical Resrearch Coordinator will coordinate day-to-day activities for clinical research protocols for the Pulmonary Critical Care Faculty at Fred Hutch for while demonstrating competence in clinical research skills, problem-solving, and priority setting. The Project Coordinator will participate in the planning, coordination and implementation of complex investigator-initiated clinical research studies involving human subjects, including a multi-year, multi-center observational study of lung disease in cancer patients. This individual will be required to perform their responsibilities with a high level of independence within the scope of study protocol(s) and institutional guidelines, and collaborate with a multi-disciplinary clinical and research team. This individual will report directly to the Investigator in the Pulmonary Section in the Clinical Research Division.
Study Conduct / Clinical Research Practice:
Work independently in performing daily responsibilities required to plan and execute clinical research trials and non-intervention protocols.
Coordinate research and administrative activities related to studies, ensuring all projects are completed according to project timelines.
Screen, enroll, and follow research subjects, complete case report forms (CRFs), place physician orders, coordinate research study visits, communicate with the primary care teams, and research subjects.
Meet with Investigator on a regular basis to monitor study data and implement patient communication procedures as per study protocol.
Interact with research subject to ensure compliance with study procedures involving home monitoring of lung function and sample collection.
Coordinate specimen collection, transport, processing, storage, and shipment procedures according to protocol requirements. Track and maintain research supplies.
Serve as a projectliaison for 1) home health monitoring company involved in clinical study, 2) secondary sites for project start-up and QI, and 3) other Fred Hutch and Seattle Cancer Care Alliance departments involved in the study.
On assigned interventional clinical trials, act as the main protocol resource person for the investigator and/or research sponsor, research subjects, local and central labs, monitors, primary care teams, and investigational pharmacy staff.
Collaborate with investigators and clinical staff to ensure appropriate identification, enrollment, and follow-up of subjects for completion of study activities.
Train others as needed and develop standard operating procedures (SOP) or other necessary documents for standardized study conduct.
Ensure accurate enrollment records are maintained and up to date.
Create source documents or CRFs as needed to promote efficient data collection and entry.
Review CRFs to ensure completeness, accuracy, and compliance with Good Clinical Practice.
Identify and report any adverse events in accordance with protocol, regulatory guidelines, and institutional policy.
Protocol Development and Implementation:
Help review, update, and develop standard operating procedures for research protocols as needed.
Develop and maintain tools for study implementation, which may include data collection tools, study reference materials, and study specific orders. Revise and utilize tools as necessary to fulfill the aims of the clinical trial.
Regulatory Compliance and Documentation:
Facilitate protocol monitoring visits and collaborate with study monitors to resolve data discrepancies and procedural issues.
Provide input to the regulatory coordinator on protocol document submissions and continuing review reports.
Prepare or assist in preparing consent forms, continuation review reports, protocol modifications, serious adverse event reports, and other study reports.
Perform retrospective chart review as required
Travel for investigator meetings to secondary sites for study start-up
Other duties as assigned
A bachelor's degree is required.
Computer experience including electronic CRF, MS Office including Excel, Outlook, PowerPoint and Access.
Excellent written and communication skills, attention to detail, high-level organization, leadership ability, and the flexibility to work in collaboration with a multi-disciplinary team.
One-year post-masters or two years post-bachelors project coordination experience in a research setting.
Agility with smartphone technology and web-based databases is desirable.
Knowledge using and building REDCap databases is desirable.
Certified Clinical Research Coordinator (ACRP), Certified Clinical Research Professional (SOCRA), or equivalent certification.
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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.