Clinical Research Coordinator I

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers. 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 value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.

The position will work directly with an Associate Professor and Project Manager in the Infectious Disease Sciences Program in the Vaccine and Infectious Disease Division to provide support to the Principal Investigator and research staff in the development, implementation and management of his diverse research portfolio, including research studies and clinical trials.

The Clinical Research Coordinator I (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 industry-sponsored clinical trials, in addition to 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 Assistant Professor, the CRC will manage a portfolio of clinical 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/ UW system.

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/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, 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.

MINIMUM QUALIFICATIONS:

• High school diploma or equivalent.
  
• Minimum one year experience in a clinical research or cancer registry environment with regulatory or human research protections.
  
• Demonstrated knowledge of how to synthesis study conduct.
  
• Ability to apply judgement in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns when appropriate.

PREFERRED QUALIFICATIONS:

• BA/BS in a life sciences field of study.
• 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.
• Ability to work in teams and independently, flexible hours at times in support of clinical trials and regulatory and related compliance.

The hourly pay range for this position is from $27.01 to $38.45 and pay offered will be based on experience and qualifications.

Although Fred Hutch is not sponsoring most H-1B visas at this time, candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.

Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), and paid parental leave (up to 4 weeks).