Clinical Research Coordinator II

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 II is responsible for coordinating interventional Phase I-III clinical trials and observational Cancer Control studies while providing flexible support across disease programs and research teams. The position manages subject-level study activities including participant screening and enrollment, visit coordination, study documentation, data collection and reporting, and research specimen management. The coordinator collaborates with investigators, study teams, and Data Coordination staff within Clinical Research Support to ensure the successful execution of research studies and continuity of research operations.

Reporting to the Senior Manager/Manager of Clinical Trials Coordination, the coordinator will serve as part of the Clinical Trial Support Team, providing flexible clinical research coordination support across disease programs and care settings. This position may be deployed to support staffing coverage needs, enrollment growth, study startup activities, and other operational priorities while ensuring continuity of research operations. The coordinator is expected to rapidly integrate into new study teams and maintain high-quality study conduct in accordance with protocol, regulatory, and institutional requirements.

This position is key to the smooth operation of clinical trials and advancing research efforts at Fred Hutch.

At Fred Hutchinson Cancer Center, all employees are expected to demonstrate a commitment to our values of collaboration, compassion, determination, excellence, innovation, integrity, and respect.

Responsibilities

- Conduct daily clinical operations of assigned research studies in accordance with study protocols, regulatory and GCP guidelines, and institutional policy while providing flexible support across disease programs, research teams, and community sites based on organizational priorities.

- Develop and maintain tools for study implementation, including data collection tools, reference materials, and specific study orders; revise and utilize tools as necessary to support study continuity and efficient onboarding to new assignments.

- 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.

- Provide temporary operational support during staffing vacancies, leaves of absence, enrollment surges, study startup activities, and other identified business needs to ensure continuity of research operations.

- 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 across multiple studies and disease programs.

- 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 and cross-training opportunities.

- 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.

- May travel between clinical and research locations, including our Community Sites, to support study operations, participant visits, research specimen handling, monitoring activities, and other research-related responsibilities.

- Demonstrate the ability to rapidly integrate into new research teams, disease programs, and study portfolios while maintaining high-quality study conduct and participant support.

- Other duties as assigned.

Qualifications

MINIMUM QUALIFICATIONS:

- 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.

- Knowledge of clinical trials records, procedures, and computerized data processing systems.

- Demonstrated knowledge of how to synthesize study conduct.

PREFERRED QUALIFICATIONS:

- Associate's or bachelor's degree in a healthcare, life sciences, public health, or 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 working with NIH, FDA, OHRP, and ICH-GCP regulations, clinical research databases, and electronic medical records.

- Previous experience working with NIH, FDA and OHRP regulations and medical terminology.

- Excellent organizational skills, attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment.

- Strong written and verbal communication skills, including computer skills.

- Ability to work with multiple data management systems including generating reports and sourcing data from systems.

- Ability to extract data from medical records and apply judgement in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns when appropriate.

The hourly pay range for this position is from $32.63 to $48.93 and pay offered will be based on experience and qualifications.Although Fred Hutch is not sponsoring most H-1B visas at this time, candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), and paid parental leave (up to 4 weeks).

## Additional Information
We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to Human Resources at [email protected] or by calling 206-667-4700.