Clinical Research Coordinator II - Phase 1

Fred Hutchinson Cancer Center•Seattle, WA

About The Position

The Clinical Research Coordinator II is responsible for the day-to-day coordination of interventional Phase I clinical trials within Fred Hutch’s Phase 1 Clinical Trials Program. The coordinator oversees subject-level study workflows, including screening for eligibility, enrollment, tracking visits, abstracting and reporting data, coordinating research specimen collection and submission, and creating and maintaining research documentation. The role collaborates with Data Coordination staff on the Clinical Research Support team and reports to the Associate Director of Clinical Trials Coordination. The position supports the smooth operation of clinical trials and Fred Hutch’s research efforts. Fred Hutchinson Cancer Center is an independent nonprofit organization focused on adult cancer treatment and research in cancer and infectious diseases. The organization operates clinical care sites and works through hospital network affiliations. Employees are expected to demonstrate collaboration, compassion, determination, excellence, innovation, integrity, and respect.

Requirements

High school diploma or equivalent.
Two to three years of experience in a clinical research or cancer registry environment involving regulatory or human research protections.
Knowledge of clinical trial records, procedures, and computerized data processing systems.
Demonstrated knowledge of how to synthesize study conduct.

Nice To Haves

Associate’s or bachelor’s degree in healthcare, life sciences, public health, or a related field.
Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP/SOCRA), or equivalent certification.
Experience coordinating clinical research studies, including participant enrollment, informed consent, study visits, data collection, and research documentation.
Experience with NIH, FDA, OHRP, and ICH-GCP regulations, clinical research databases, and electronic medical records.
Previous experience with NIH, FDA, and OHRP regulations and medical terminology.
Excellent organizational skills, attention to detail, problem-solving ability, and ability to prioritize competing tasks in a dynamic environment.
Strong written and verbal communication skills, including computer skills.
Ability to work with multiple data management systems, generate reports, and source data from systems.
Ability to extract data from medical records, use judgment to interpret regulations and determine impacts, and recognize when to escalate questions and concerns.

Responsibilities

Conduct daily clinical operations for assigned research studies in accordance with study protocols, regulatory and GCP guidelines, and institutional policy.
Develop, maintain, revise, and use study implementation tools, including data collection tools, reference materials, and study-specific orders.
Provide study-specific education and training to clinic staff, participants, and other stakeholders.
Review candidates’ medical records for eligibility, initiate enrollment, ensure informed consent, and maintain accurate enrollment records.
Schedule clinic and ongoing study visits and ensure protocol compliance for clinical procedures, laboratory tests, and other patient activities.
As applicable, administer study questionnaires, perform non-clinical ECGs, and support investigational product accountability, participant education, documentation, reconciliation, and pill counts.
Complete clinical requisition forms, assemble patient visit kits, transport laboratory samples, ensure samples are processed and shipped according to study guidelines, and track research supplies.
Identify, track, and confirm billable patient activities; work with internal partners on budget and billing information; and, as applicable, help review patient charges for billing compliance.
Serve as a protocol liaison among clinical teams, patients, providers, sponsors, and research staff regarding study activities and requirements.
Prepare and coordinate monitoring visits, respond to study monitor queries and requests, and follow up to resolve issues.
Maintain current knowledge of clinical research regulations, GCP, protocol requirements, and research best practices through professional development.
Maintain appropriate source documentation and enter case report form data, ensuring timely, accurate, and complete study records.
Travel from the South Lake Union campus to UW Medical Center Montlake to oversee transit of collected research specimens for processing and shipment.
May travel to industry-sponsored investigator meetings.
Perform other duties as assigned.