Clinical Research Coordinator I
Overview
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.
We are looking for a Clinical Research Coordinator to join our dynamic team of dedicated and skilled research staff working on clinical trials in the field of hematologic malignancies. The Clinical Research Coordinator will participate in the planning, coordination, and implementation of multiple clinical trials involving human subjects. The focus of this position will be on coordinating trials run through the National Cancer Institute’s (NCI) National Clinical Trial Network (NCTN).
This individual will work under the supervision of the Clinical Program Operations Director and will be required to perform responsibilities with a high level of independence within the scope of study protocols and institutional guidelines.
Responsibilities
- 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 in detail 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. Coordinate and communicate regularly with study counterparts at Clinical Research Support.
- 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 trials.
- Initiate scheduling of patient clinic visits and on-going study visits. Attend patient visits and ensure clinical procedures, lab tests, and other protocol specific activities are completed as outlined in the protocols
- 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 and other protocol-driven non-clinical assessments
- Function as a protocol liaison with clinical teams, patients, and when necessary, other institutions or drug companies
- 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 in a timely manner
- Understand clinical trial budget and billing plans for patients enrolled on clinical trials
- Provide input regarding IRB correspondence and regulatory documentation
- As needed, identify and report adverse events in accordance with protocol, regulatory guidelines, and institutional policy
- As needed, 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
- Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature, and maintaining professional associations
- Provide back up for other Clinical Research Coordinators as needed. Provide back up for Data Coordinator on applicable trials.
- Other duties as assigned
Qualifications
Minimum qualifications:
- High school diploma or equivalent
- Minimum of 1 year 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
- Must be a self-starter with the ability to locate resources and operate productively in an environment where standard operating procedures, guidelines and policies are not always available
- Collaborative focus is essential, as well as strong written and verbal communication skills, including computer skills
- Onsite work is required for patient visits. Must have the flexibility to manage patients visits that occur before or after regular work hours.
Preferred qualifications:
- Associate or Bachelor's degree in a related field
- 2+ years of clinical research or relevant/related experience
- CCRP or CCRC accreditation
- Previous experience in oncology research
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.