Clinical Research Coord I/II--J. Hill Group

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.   

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The position will work directly with an Assistant Member in the Infectious Disease Sciences Program in the Vaccine and Infectious Disease Division to provide support to the PI and research staff in the development, implementation and management of his diverse research portfolio, including research studies and clinical trials.

 

The Clinical Research Coordinator (CRC) will be responsible for providing support on all aspects of research study and clinical trial development and implementation. Primary responsibilities of the CRC will include assistance with the planning, coordination, implementation, and close-out (e.g. presentation of data, manuscript writing) of retrospective and prospective observational or investigator-initiated interventional studies. Additional responsibilities will include communicating with internal and external collaborators and supporting study personnel in the preparation of regulatory documentation and audits if applicable.

 

Under the supervision of the Principal Investigator and Research Project Manager, the CRC will manage a portfolio of complex research projects and will be required to perform their responsibilities with a high level of independence within the scope of study protocol(s) and institutional guidelines. The position will include interaction with patients, physicians, researchers, and other clinical providers and support staff within and outside of the Fred Hutch Cancer Center(FHCC)/UW system including the FHCC Patient Care Services.

• Prepares study start-up documentation including FDA submissions, eligibility checklists, study-specific clinic orders and study calendars
• Research, maintain, analyze, and abstract patient clinical trial data from pre-study background (e.g., previous diagnoses and treatments) through clinical trial participation and long-term follow-up
• Ensures patient eligibility requirements for clinical trials are met, assists in patient enrollment, screens and registers patients on study
• Understand and interact with departments and automated electronic medical record systems throughout Fred Hutch/SCCA/UW system to ensure timely and complete delivery of data
• Track status of potential and active clinical trial participants
• Create and maintain the study’s manual of operations and laboratory manual
• Create and maintain a REDCap database or equivalent for collection of study data. Abstracts data from medical records to complete study-specific case report forms. Maintains shadow chart with source documents. Assists in the development of data acquisition forms and instructions for completion.
• Schedules study related clinic procedures such as blood draws, infusions and treatment according to protocol requirements; coordinates with clinic staff to ensure proper documentation and timing of research-related procedures
• Coordinate and support regularly scheduled Sponsor or institutional monitoring visits to ensure quality and completeness of data. Responds to all findings and implements corrective action as necessary.
• Coordinate long-term follow-up evaluations and data collection with clinical trial participants, SCCA, and participants’ local physicians
• Serve as a liaison and reference resource to Physicians, Investigators, other staff members, and other organizations with questions about data collection or protocol procedures and requirements
• Coordinate special projects regarding data collection, analysis, output, and presentation
• Ensures compliance with ongoing reporting requirements to the Food and Drug Administration, National Institutes of Health, Human Subjects Committee, Institutional Review Board, Pharmaceutical
• Companies, and other agencies, to include annual reports, study amendments, safety reports, and unanticipated problem/noncompliance reports

• Clinical Research Coordinator I Minimum Education/Experience:
  • Bachelor's degree or equivalent
  • Minimum one to three years' experience in a clinical research or cancer registry environment with regulatory or human research protections.
• Clinical Research Coordinator II Minimum Education/Experience:
  • Bachelor's degree or equivalent
  • Minimum four to six years' experience in a clinical research or cancer registry environment with regulatory or human research protections.
  • Certified Clinical Research Coordinator (CCRC) or certification as Clinical Research Professional (SOCRA).
• 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
• Ability to work in teams and independently, flexible hours at times in support of clinical trials and regulatory and related compliance
• Knowledge of medical terminology is required
• Knowledge of federal regulations and guidelines that govern clinical research, including GCP and human subjects research
• Able to assess risk in the conduct of clinical research
• Previous experience in oncology research and clinical data collection is preferred 
• Clinical research related certification is preferred

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.

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.