Phase I Clinical Trials Coordinator II

Fred Hutchinson Cancer Center; Seattle (WA); On-site; USD 45,000 - 67,000; Full time

Benefits offered by this job

Medical, vision, and dental benefits

Tuition reimbursement

Paid vacation

Paid sick leave

Paid holidays

Paid parental leave

Job summary

Fred Hutchinson Cancer Center in Seattle is seeking a Clinical Research Coordinator II to manage day-to-day coordination of interventional Phase I trials. You will screen patients, enroll participants, track visits, and ensure data accuracy across study records.

Reporting to the Associate Director of Clinical Trials Coordination, you'll collaborate with Data Coordination and research teams, maintain protocol compliance, and travel between campus sites as needed to oversee specimen transport.

Qualifications

• 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.

Responsibilities

• Conduct daily clinical operations of assigned research studies per protocol and regulatory guidelines.
• Develop and maintain tools for study implementation and data collection.
• 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 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.
• 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 coordination

Regulatory knowledge

Data management

Communication skills

Education

Associate's or bachelor's degree in healthcare, life sciences, public health, or related field

Certification in clinical research

Tools

Electronic Medical Records (EMR) systems

Clinical research databases

Job description

Fred Hutchinson Cancer Center in Seattle is seeking a Clinical Research Coordinator II to manage day-to-day coordination of interventional Phase I trials. You will screen patients, enroll participants, track visits, and ensure data accuracy across study records.

Reporting to the Associate Director of Clinical Trials Coordination, you'll collaborate with Data Coordination and research teams, maintain protocol compliance, and travel between campus sites as needed to oversee specimen transport.