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. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first 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.
At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.
The Clinical Research Coordinator will participate in the planning, coordination, and implementation of investigator-initiated and industry- sponsored clinical research studies for hematopoietic cell transplantation, with a focus on chronic graft versus host disease.
The incumbent is responsible for Investigational New Drug submissions, Institutional Review Board documentation, screening patients for eligibility, tracking patient visits, coordinating clinic procedures, and the collection, abstracting, reporting, and quality control of clinical trial data in accordance with protocols subject to FDA oversight. They are also for coordination of multi-site studies and the long-term follow-up activities associated with these protocols. Serve as a resource to other investigative trial sites to accomplish study goals.
This individual will work under the supervision of the Principal Investigator, will report regularly to the PI on study progress, and will be required to perform their responsibilities with a high level of independence within the scope of study protocol(s) and institutional guidelines. Uses judgment in data collection, quality control, liaison, and research coordination activities. Interacts with patients, physicians, and other clinical providers and support staff within and outside of the Fred Hutch / University of Washington / Seattle Cancer Care Alliance (SCCA) system including the SCCA Transplant Service.
- 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
- Assist the Principal Investigator (PI) with protocol development, revision, and study analysis
- 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
- 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
- Administer study questionnaires
- 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
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.
- Participate in the review of charges for patients on clinical trials to ensure billing compliance
Other Duties Which May Be Required
- 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, and other study reports.
- Travel for industry sponsored investigator meetings, if interested
- Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature, and maintaining professional associations
- Bachelor’s degree in life sciences required
- Minimum of 2 years of clinical research or related experience
- 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
- Previous experience in oncology research and clinical data collection is preferred
Applicants must include a cover letter to be considered
A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and anti-racism in your career or that will be made through work at Fred Hutch is requested of all finalists.
Our Commitment to Diversity
We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at email@example.com or by calling 206-667-4700.