Clinical Research Coordinator I

Fred Hutch Cancer Center; Seattle (WA); On-site; USD 60,000 - 90,000; Full time

Job summary

Fred Hutchinson Cancer Center in Seattle is seeking a Clinical Research Coordinator I to coordinate day-to-day activities for assigned infectious disease science protocols. The role requires independent work under supervision, collaboration with a multidisciplinary team, and adherence to Good Clinical Practice.

Responsibilities include planning and executing investigator-initiated and industry-sponsored trials, coordinating study activities, and ensuring accurate documentation.

Qualifications

• Experience coordinating clinical research studies.
• Understanding of Good Clinical Practice (GCP) and regulatory requirements.
• Ability to develop and follow standard operating procedures.

Responsibilities

• Plan, coordinate, and implement investigator-initiated, industry-sponsored and cooperative studies.
• Collaborate with multi-disciplinary teams and supervise study staff.
• Screen, enroll and follow subjects, prepare CRFs and source documents.
• Coordinate specimen collection, transport, processing, storage, and shipment per protocol.
• Review CRFs for completeness and accuracy; report adverse events per guidelines.
• Assist with protocol development, budgeting, and feasibility assessments.

Skills

Clinical research coordination

GCP knowledge

Regulatory compliance

Budgeting basics

Data collection tools

Job description

Overview

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 (CRC) will coordinate day-to-day activities for assigned clinical research protocols for Infectious Disease Sciences Program faculty while demonstrating competence in clinical research skills, problem-solving, and priority setting.

Responsibilities

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 for three different faculty members. This individual will work under the supervision of a faculty member 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:

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, funding sources, 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.
• 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 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.
• Create source documents or CRFs as needed to promote efficient data collection and entry.
• 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 an