Clinical Research Coordinator I
Overview
Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.
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.
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. Responsible 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.
Applicants must include a cover letter to be considered.
Responsibilities
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 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 FHCRC/SCCA/UW 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
- Review study candidates’ medical records for study eligibility
- Assist the Principal Investigator (PI) with protocol development, revision, and study analysis
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
Enrollment
- Ensure informed consent, initiate patient enrollment, and ensure accurate enrollment records are maintained
Education
- Educate clinical teams, ancillary departments, and patients to ensure safe and accurate protocol implementation
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
- 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
- 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
- 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
- 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
Qualifications
- Bachelor’s degree in life sciences
- Minimum of one to two years of clinical research or related experience
- Excellent organizational skills, attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment
- Collaborative focus is essential
- Strong written and verbal communication skills, including computer skills
In addition to job duties at Fred Hutch, this position also requires access to Seattle Cancer Care Alliance, which requires COVID-19 vaccination without exceptions.
Accordingly, as a condition of employment for this Fred Hutch position, newly hired employees must provide proof of vaccination before their first day of employment.
A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your 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 hrops@fredhutch.org or by calling 206-667-4700.