Phase I Clinical Research Coordinator II - Impactful Trials

Fred Hutchinson Cancer Center (Fred Hutch); Seattle (WA); On-site; USD 68,000 - 102,000; Full time

Benefits offered by this job

Health benefits

Paid time off

Tuition reimbursement

Job summary

Fred Hutchinson Cancer Center in Seattle is seeking a Clinical Research Coordinator II for Phase I trials. You will oversee day-to-day study operations, screen patients, enroll participants, track visits and manage data.

Collaborate with data coordination teams to ensure regulatory compliance and timely reporting. Strong organizational skills and knowledge of GCP/FDA/NIH regulations are preferred.

Qualifications

• 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.
• Demonstrated knowledge of how to synthesize study conduct.
• Experience coordinating clinical research studies, including participant enrollment, informed consent, study visits, data collection, and research documentation.

Responsibilities

• Conduct daily clinical operations of assigned research studies in accordance with study protocols, regulatory and GCP guidelines, and institutional policy.
• Develop and maintain tools for study implementation, including data collection tools, reference materials, and specific study orders; revise and utilize tools as necessary.
• Provide study-specific education and training to clinic staff, participants, and other stakeholders to support accurate and compliant protocol implementation.
• Coordinate patient enrollment and participation by reviewing study candidates' medical records for eligibility, initiating enrollment, ensuring informed consent, and maintaining accurate enrollment records.
• Schedule patient clinic visits and ongoing study visits; ensure administrative compliance with study protocols with respect to clinical procedures, laboratory tests, and other patient activities; may administer study questionnaires, perform non-clinical ECGs, and support investigational product accountability activities, including participant education, documentation, reconciliation, and pill counts for participant-managed study medications, as applicable.
• Complete clinical requisition forms as instructed, assemble kits for patient visits, transport laboratory samples, and ensure samples are processed and shipped according to study guidelines; track and maintain research supplies.
• 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.
• Serve as a protocol liaison with clinical teams, patients, providers, sponsors, and research staff regarding study-related activities and protocol requirements.
• Prepare and coordinate monitoring visits and respond to queries and other requests from study monitors, following up on and resolving any issues that may arise.
• Maintain current knowledge of clinical research regulations, GCP, protocol requirements, and research best practices through ongoing professional development activities.
• May travel to attend industry-sponsored investigator meetings.
• Maintain appropriate source documentation and perform case report form data entry, ensuring timely, accurate, and complete study records in accordance with protocol and regulatory requirements.
• Travel from the South Lake Union campus to UW Medical Center Montlake to oversee the transit of collected research specimens for processing and shipment.
• Other duties as assigned.

Skills

Clinical research experience

Regulatory knowledge

Data management

Communication skills

Education

Associate's or Bachelor's degree in healthcare or life sciences

Tools

Electronic Medical Records

CRF data entry

Budgeting & billing tools

Job description

Fred Hutchinson Cancer Center in Seattle is seeking a Clinical Research Coordinator II for Phase I trials. You will oversee day-to-day study operations, screen patients, enroll participants, track visits and manage data.

Collaborate with data coordination teams to ensure regulatory compliance and timely reporting. Strong organizational skills and knowledge of GCP/FDA/NIH regulations are preferred.