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 Research Coordinator will manage the planning, coordination, and implementation of complex investigator-initiated, industry-sponsored, and cooperative group clinical research studies of graft-versus-host disease (GVHD). This individual will work under the supervision of the Clinical Program Operations Director and will be required to perform their responsibilities with a high level of independence within the scope of study protocol(s) and institutional guidelines.
Principal Investigator Support:
Serve as designee of the Principal Investigator (PI) to manage the daily clinical operations of assigned research studies in accordance with regulatory, GCP guidelines and institutional policy.
Review study candidates medical records for study eligibility.
Ensure informed consent, initiate patient enrollment, and ensure accurate enrollment records are maintained.
Educate clinical teams, ancillary departments, and patients to ensure safe and accurate protocol implementation.
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.
Initiate scheduling of patient clinic visits and on-going study visits. Ensure clinical procedures, lab tests, and other protocol-specific activities are completed as outlined in the protocols.
Manage or delegate sample acquisition: Complete requisition forms, assemble kits for upcoming research visits, transport laboratory samples, and ensure samples are processed and shipped according to study specific guidelines, while tracking and maintaining research supplies.
Budget & Billing
Understand clinical trial budget and billing plans for patients enrolled on clinical trials.
Collaborate with Investigational Drug Services (IDS) on drug assignment, dispensing information, and maintain regular communication regarding status of study subjects.
Ensure study drug self-administration and accountability with patients.
Perform non-clinical ECGs.
Administer study questionnaires.
Function as a protocol liaison with clinical teams, patients, and when necessary, other institutions or drug companies.
Maintain or assist in maintaining IRB correspondence and regulatory documentation.Prepare or assist in preparing consent forms, continuation review reports, protocol modifications, serious adverse event reports and other study reports.
Maintain appropriate sourcedocumentation, and complete or delegate accurate data entry into case report forms in a timely manner.
Delegate or coordinate monitoring visits and respond to queries and other requests from study monitors.
Identify and report adverse events in accordance with protocol, regulatory guidelines, and institutional policy.
Participate in the review of charges for patients on clinical trials to ensure billing compliance.
Travel for industry sponsored investigator meetings.
Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature, and maintaining professional associations.
Other duties as assigned.
Bachelors degree required
Applicant must have a minimum of five years of clinical oncology research experience, preferably in hematopoietic stem cell transplantation
This position requires excellent organizational skills, attention to detail, high motivation, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment and work independently
Collaborative focus is essential, as well as strong written and verbal communication skills, including computer skills
Candidates must be available to work on-call (rare weekend enrollment responsibilities)
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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.