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 with minimal side effects. 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 Clinical Research Coordinator will participate in the planning, coordination, and implementation of complex investigator-initiated and industry-sponsored clinical research studies involving human subjects. The position functions as a team member under the overall direction of the Principal Investigators. This individual will work under the supervision of the Research Manager and will be required to perform his/her 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.
- 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.
- Work with internal partners to obtain and submit budget and billing information.
Other Duties Which May Be Required:
- Assist the Principal Investigator (PI) with protocol development, revision, and study analysis.
- Collaborate with Investigational Drug Services (IDS) on drug assignment, dispensation 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 source documentation, and complete or assist with accurate data entry into case report forms in a timely manner.
- 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.
Associate degree required, with Bachelor's degree preferred. Applicant must have a minimum of two to three years of clinical 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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