Clinical Research Coordinator II/III

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. These values are grounded in and expressed through the principles of diversity, equity and inclusion. 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. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

The Clinical Research Division at Fred Hutch is seeking a Clinical Research Coordinator to join our dynamic team of dedicated and skilled research staff working on clinical trials in hematologic malignancies. The Clinical Research Coordinator will participate in the planning, coordination, and implementation of multiple industry- sponsored and investigator-initiated oncology clinical trials involving human subjects.

This individual will work under the supervision of the Clinical Program Operations Manager and will be required to perform his/her responsibilities with a high level of independence within the scope of complex study protocol(s) and institutional guidelines. This role requires demonstrated knowledge of study management, in addition to regulatory and/or clinical operations.

This role will have the opportunity to work partially at our campus and remotely.

Protocol Management

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.
• Function as protocol liaison with clinical teams, subjects, and when necessary, other institutions.
• Review study candidates' medical records in detail for study eligibility.
• Ensure informed consent is performed, initiate patient enrollment, and maintain accurate enrollment records.
• Educate clinical teams, ancillary departments, and patients to ensure safe and accurate protocol implementation.
• Develop and utilize tools for study operation, which may include data collection tools, study reference materials, and study specific orders. Revise and implement tools as necessary to fulfill the aims of the clinical trial.
• Monitor and track upcoming patient visits. 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.
• Assemble kits for patient visits, transport laboratory samples and ensure samples are processed and shipped according to study guidelines; track and maintain research supplies.
• Collaborate with Investigational Drug Services (IDS) and/or Nuclear Medicine on drug assignment, dispensation information, and maintain regular communication regarding status of study subjects.
• Identify, track, and confirm billable activities for patients; work with internal partners to obtain and submit budget and billing information; may assist in reviewing patient charges to ensure billing compliance.
• Identify and report adverse events in accordance with the protocol, regulatory and institutional guidelines, and policies.
• Serve as coordinator back-up when other support is unavailable, in cases of vacation, illness, and other absences.

Administrative

• Assist in study start-up and amendment activities through communication with central teams and sponsors, identifying potential issues or barriers, and remediation.
• Review protocol amendments with an eye to operational and regulatory impacts, assist with operationalization and re-education.
• With the Clinical Program Operations manager, identify training needs and develop remedial plans and organizational tools.
• Collate and establish study-specific research and reference binders.
• File requisitions and other research documentation in each patients' research chart.
• Assist with maintaining regulator folders in the electronic Binder system.
• Coordinate monitoring visits and respond to queries and other requests from study monitors.
• Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature, and maintaining professional associations.
• Perform other duties as assigned.

MINIMUM QUALIFICATIONS:

Clinical Research Coordinator II

• High school diploma or equivalent.
• Minimum two to three years' experience in a clinical research or cancer registry environment with regulatory or human research protections.

Clinical Research Coordinator III

• Bachelor's Degree in scientific/medical field or equivalent combination of education and experience.
• Six or more years of experience in medical records, cancer registry, clinical study coordination or related field.

Both Levels

• 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 with strong written and verbal communication skills, including computer skills.
• Must have the flexibility to manage patient visits that may occur before or after regular work hours.
• Flexibility with work schedule required as required in-person work will be driven by research patient visits, which will be variable.
• Knowledge of clinical trials records, procedures, and computerized data processing systems.
• Knowledge of medical terminology.
• Ability to extract data from medical records.
• Ability to apply judgement in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns when appropriate.
• Strong computer skills, including proficiency in Excel and Word, and experience working with databases.
• Strong verbal and written communication skills.

PREFERRED QUALIFICATIONS:

Clinical Research Coordinator II

• Associate or bachelor's degree.
• 2+ years of oncology clinical research or relevant/related experience or 4+ years of non-oncology clinical research experience.

Clinical Research Coordinator III

• Advanced Degree (Master's level or higher) in the scientific/medical field.