Clinical Research Coordinator I/II

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 Clinical Research Coordinator I/II (CRC) will coordinate day-to-day activities for assigned clinical research protocols for the Infectious Disease Sciences Program while demonstrating competence in clinical research skills, problem-solving, and priority setting. This position supports COVID-19 and non-COVID-19 clinical research studies/trials.

The incumbent will participate in the planning, coordination, and implementation of complex investigator-initiated, industry-sponsored, and cooperative group clinical research studies involving human subjects. This individual will work under the supervision of the Senior Clinical Research Manager and will be required to perform their responsibilities with a high level of independence within the scope of study protocol(s) and institutional guidelines. Collaborate with a multi-disciplinary team and provide guidance to other study staff in carrying out research implementation tasks.

Perform some or all the following responsibilities assigned based on the level CRC I and or CRC II:

Study Conduct / Clinical Research Practice
• Work independently in performing daily responsibilities required to plan and execute investigator driven/industry-based clinical research trials and non-intervention protocols.
• Coordinate research and administrative activities related to studies, ensuring all projects are completed according to project timelines.
• Serve as project liaison, representing the project to other center departments, affiliated individuals or institutions, and outside organizations.
• On assigned projects, act as the main protocol resource person for the investigator and/or research sponsor, research subjects, local and central labs, monitors, primary care teams, and investigational pharmacy staff.
• Initiation and completion of Central Startup for both industry sponsored and PI initiated studies
• Collaborate with investigators and coworkers to ensure completion of study activities
• Train others as needed and develop standard operating procedures (SOP) or other necessary documents for standardized study conduct.
• Screen and recruit subjects either within the consortium or the community dependent upon study specific requirements, enroll, and follow research subjects, complete case report forms (CRFs), place physician orders, coordinate research study visits, communicate with the primary care teams, investigational pharmacy staff and research subjects.
• Travel to University of Medical Center and the Fred Hutch Outpatient Clinic will be required for the enrollment of study subjects.
• Ensure accurate enrollment records are maintained and up to date.
• Coordinate specimen collection, transport, processing, storage, and shipment procedures according to protocol requirements. Track and maintain research supplies.
• Review CRFs to ensure completeness, accuracy, and compliance with Good Clinical Practice.
• Identify and report any adverse events in accordance with protocol, regulatory guidelines, and institutional policy.

Protocol Development and Implementation

• Help develop and review research protocols for feasibility and collaborate with study leadership to develop the study budget and implementation plans.
• 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.

Budget and Billing

• Prepare requests for research prices on study activities and coordinate the research billing start-up process.
• Review, reconcile, and approve research study bills. Work closely with the IDS fiscal staff to ensure accurate research billing and reimbursement.

Regulatory Compliance and Documentation

• Facilitate protocol monitoring visits and collaborate with study monitors to resolve data discrepancies and procedural issues.
• Provide input to the regulatory coordinator on protocol document submissions and continuing review reports.
• Prepare or assist in preparing consent forms, continuation review reports, protocol modifications, serious adverse event reports, and other study reports.

Other Duties Which May Be Required:

• Perform retrospective chart review as required
• Travel for investigator meetings
• Will require weekends and holiday coverage for clinical studies.
• Other duties as assigned

MINIMUM QUALIFICATIONS:
Clinical Research Coordinator I

• 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.
• 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.

Clinical Research Coordinator II

• All qualifications of Clinical Research Coordinator I, plus:
• Minimum two to three years' experience in a clinical research or cancer registry environment with regulatory or human research protections.
• Knowledge of clinical trials records, procedures, and computerized data processing systems.
• Ability to work with multiple data management systems including generating reports and sourcing data from systems.
• Ability to extract data from medical records.

PREFERRED QUALIFICATIONS:

• Bachelor's degree preferred
• Minimum five years of experience in a research environment with regulatory or human research protections.
• Previous work experience in conducting interventional clinical trial trials
• Computer experience including electronic various CRF platforms, MS Office including Excel, Outlook, PowerPoint
• Excellent written and oral communication skills, leadership ability, and the flexibility to work in collaboration with a multi-disciplinary team.
• Previous experience in oncology research and clinical data collection is preferred
• Knowledge using REDCap databases.
• Desired Certified Clinical Research Coordinator (ACRP), Certified Clinical Research Professional (SOCRA), or equivalent certification
• Previous experience working with NIH, FDA and OHRP regulations and medical terminology.
• Knowledge of clinical trials records, procedures, and computerized data processing systems. Ability to extract data from medical records.

The hourly pay range for the Clinical Research Coordinator I is from $26.48 to $37.70 and pay offered will be based on experience and qualifications.

The hourly pay range for the Clinical Research Coordinator II is from $31.21 to $46.80 and pay offered will be based on experience and qualifications.

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), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).