Clinical Research Coordinator II - Phase 1

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

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 ClinicalResearch CoordinatorIIis responsible forday-to-day coordination of interventional Phase I clinical trials. The position will oversee all subject-level study workflows including screening patients for eligibility, performing enrollments, tracking patient visits,abstractingand reporting study data, coordinating research specimen collection and submission, and creating andmaintainingresearch documentation. Collaborates with Data Coordination staff on the Clinical Research Support team.

Reporting to the Associate Director of Clinical Trials Coordination, the coordinator will be part of Phase 1 Clinical Trials Program.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 todemonstratea commitmentto our values of collaboration, compassion, determination, excellence, innovation, integrity, and respect.

Responsibilities

• Conductdaily clinical operations of assigned research studiesin accordance withstudy protocols, regulatory and GCP guidelines, and institutional policy.
• Developandmaintaintools for study implementation, including data collection tools, reference materials, and specific study orders; revise andutilizetoolsas necessary.
• Providestudy-specific education and training to clinic staff, participants, and other stakeholders to supportaccurateand compliant protocol implementation.
• Coordinatepatient enrollment and participation by reviewing study candidates' medical records for eligibility,initiatingenrollment, ensuring informed consent, andmaintainingaccurateenrollment records.
• Schedulepatient 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.
• Completeclinical requisition forms as instructed, assemble kits for patient visits, transport laboratory samples, and ensure samples are processed and shipped according to study guidelines; track andmaintainresearch supplies.
• Identify, track, and confirm billable activities for patients; work with internal partners to obtain andsubmitbudget and billing information; mayassistin reviewing patient charges to ensure billing compliance.
• Serveas a protocol liaison with clinical teams, patients, providers, sponsors, and research staffregardingstudy-related activities and protocol requirements.
• Prepareandcoordinate monitoring visits and respond to queriesand other requests from study monitors, following up on and resolving any issues that may arise.
• Maintaincurrent knowledge of clinical research regulations, GCP, protocol requirements, and research best practices through ongoing professional development activities.
• Maytravel to attend industry-sponsored investigator meetings.
• Maintainappropriate sourcedocumentation and perform case report form data entry, ensuringtimely,accurate, and complete study recordsin accordance withprotocol and regulatory requirements.
• Travelfrom the South Lake Union campus to UW Medical Center Montlake to oversee the transit of collected research specimens for processing and shipment.
• Otherduties 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'sdegree ina 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.
• Previousexperience working with NIH, FDA and OHRPregulationsand medical terminology.
• Excellent organizational skills, attention to detail, ability to problemsolveand to prioritize multiple competing tasks in a dynamic environment.
• Strongwritten andverbal communication skills, including computer skills.
• Ability to work with multiple data managementsystemsincluding generating reports and sourcing data from systems.
• Ability to extract data from medical recordsandapply judgement in interpreting regulations,determiningimpacts, and knowing when to elevate questions and concerns whenappropriate.

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 [e-mail] or by calling 206-667-4700.