Clinical Research Coordinator I/II

RiseMe; Seattle (WA); On-site; USD 35,000 - 62,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid time off

Educational assistance

Transit subsidy

Wellness benefits

Employee assistance

Job summary

Benaroya Research Institute in Seattle seeks a Clinical Research Coordinator I/II to support translational studies in immunology. The role focuses on recruitment, coordination, data collection, and regulatory compliance within the CII, not a lab position.

The candidate will work with investigators on studies of immune mechanisms and therapies for autoimmune diseases, handling visits, consent, data, and regulatory filings to ensure study integrity and patient safety.

Qualifications

• Knowledge of FDA/ICH/GCP/HIPAA/IRB requirements
• Experience supporting clinical research activities such as recruitment, consent, data collection, and regulatory documentation
• Ability to ensure protocol compliance, data quality, and participant safety
• Familiarity with medical terminology and basic patient care procedures
• Strong organizational skills and attention to detail
• Confidentiality of participant data and study records
• Experience with clinical equipment (e.g., centrifuge, EKG) preferred
• Licensure: Medical Assistant, Phlebotomist, or Medical Assistant–Registered (may be obtained after hire)

Responsibilities

• Coordinate and conduct clinical research study visits, including scheduling and participant interaction
• Recruit, screen, and enroll study participants, obtain informed consent and collect medical history
• Collect and document clinical data, vital signs, questionnaires, and assessments
• Perform or support specimen collection and processing per protocol and licensure
• Maintain source documentation and case report forms in compliance with study requirements
• Support regulatory activities, maintain study files, submissions, and audit readiness
• Ensure compliance with study protocols, policies, and regulatory requirements (FDA, IRB, GCP)
• Coordinate participant care activities (appointments, follow-ups, communications)
• Prepare for and support monitoring visits and audits
• Maintain professional communication with participants, investigators, and staff
• Participate in quality control and process improvements
• Clinical Research Coordinator I: support start-up and day-to-day coordination under guidance
• Clinical Research Coordinator II: independently manage studies and lead start-up and recruitment strategies
• Mentor junior staff as needed

Skills

Clinical research coordination

Participant recruitment

Regulatory compliance

Data collection

Informed consent

GCP & HIPAA knowledge

IRB familiarity

Medical terminology

Organizational skills

Attention to detail

Education

Bachelor’s degree or higher in related field

Job description

Overview

The Clinical Research Coordinator I/II supports clinical studies within the Center for Interventional Immunology (CII), contributing to translational research focused on immune-mediated diseases.This role will work closely with investigators to execute clinical research studies investigating immune mechanisms and therapeutic interventions in autoimmune diseases.

This position is responsible for participant recruitment, study coordination, data collection, and regulatory compliance. It is not a lab-based role.

This position may be filled at the Clinical Research Coordinator I or II level, depending on experience. Candidates with prior clinical research experience are strongly encouraged to apply.

Responsibilities

Core responsibilities

• Coordinate and conduct clinical research study visits, including scheduling, participant interaction, and protocol-required procedures
• Recruit, screen, and enroll study participants, including obtaining informed consent and collecting medical history
• Collect and document clinical data, including vital signs, questionnaires, and study-related assessments
• Perform or support specimen collection and processing (e.g., blood draws, centrifugation) in accordance with protocol and licensure
• Maintain accurate and complete source documentation and case report forms in compliance with study requirements
• Support regulatory activities, including maintaining study files, preparing submissions, and ensuring audit readiness
• Ensure compliance with study protocols, institutional policies, and applicable regulations (e.g., GCP, FDA, IRB)
• Coordinate participant care activities such as appointment scheduling, follow-up, and communication
• Prepare for and support study monitoring visits and audits
• Maintain professional and respectful communication with participants, investigators, and clinical staff
• Participate in quality control and process improvement efforts

Clinical Research Coordinator I

• Support study start-up activities and day-to-day coordination under guidance
• Assist with recruitment strategies and participant tracking
• Learn and apply clinical research regulations, processes, and protocol requirements
• Escalate issues related to protocol deviations, participant safety, or data quality

Clinical Research Coordinator II

• Independently manage one or more studies or complex study components
• Lead study start-up activities, including protocol implementation and site preparation
• Develop and implement recruitment and retention strategies
• Ensure high-level oversight of data quality, regulatory compliance, and study timelines
• Troubleshoot operational challenges and implement process improvements
• May train or provide guidance to junior staff or new team members

Qualifications

Core qualifications

• Knowledge of clinical research practices, regulations, and terminology, including Food and Drug Administration (FDA), International Council for Harmonisation (ICH), Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPAA), and Institutional Review Board (IRB) requirements
• Experience supporting clinical research activities such as participant recruitment, informed consent, data collection, and regulatory documentation
• Ability to ensure protocol compliance, data quality, and participant safety
• Familiarity with medical terminology and basic patient care procedures
• Strong organizational skills and attention to detail
• Ability to maintain confidentiality of participant data and study records
• Experience with clinical equipment (e.g., centrifuge, EKG) preferred
• Medical Assistant, Phlebotomist, and Medical Assistant–Registered licensure required (may be obtained after hire)

Clinical Research Coordinator I

• Minimum 1 year of full-time experience in clinical research, healthcare, or a related field
• Works under close to moderate supervision
• Supports study coordination activities across one or more protocols
• Developing knowledge of regulatory requirements, study procedures, and clinical trial operations

Clinical Research Coordinator II

• Minimum 2+ years of clinical research experience with direct study coordination responsibilities
• Ability to independently manage studies or complex study components
• Experience with more complex protocols (e.g., multiple sites, investigational products, or early-phase trials)
• Strong working knowledge of regulatory processes and compliance requirements
• May provide guidance or informal mentorship to junior staff

Preferred Qualifications

• Bachelor’s degree or higher in a related field (or equivalent experience)
• Experience working with autoimmune disease or immunology-focused studies
• Prior experience with investigational product or test article handling
• Experience preparing for audits or monitoring visits
• Interest in process improvement and clinical research operations

Compensation

• Clinical Research Coordinator I - $25.66 to $37.21 hourly
• Clinical Research Coordinator II - $30.00 to $44.69 hourly

Benefits

• Medical, dental, vision insurance
• Flexible spending accounts: health care, dependent care, commuter
• Short and long-term disability
• Life and AD&D insurance
• 403(b) retirement plan with matching funds after one year of employment
• PTO: 13 holidays, three weeks of vacation and two weeks of sick leave per year
• Employee assistance program
• Educational assistance program
• Subsidized ORCA pass
• Wellness benefits
• Voluntary benefits

About Us

The Clinical Research Program at Benaroya Research Institute (BRI) works together with clinicians at Virginia Mason Medical Center to bring clinical research opportunities to patients, giving them access to clinical trials for over 100 different conditions including cancer, digestive disease, cardiology, and neuroscience. The Clinical Research Program at BRI oversees all clinical research at Virginia Mason Medical Center, combining the expertise of a world-renowned research institute with remarkable healthcare to support studies that contribute to improving the diagnosis, treatment, and prevention of a variety of diseases.

BRI is an independent, nonprofit research institute affiliated with Virginia Mason Franciscan Health and based in Seattle. Our culture is based on the values of collaboration, respect, innovation, and inquiry; team members work together to support patients and clinicians with the goal of better outcomes for all.

At BRI, each role is valued and an important contributor to our vision and mission. BRI is committed to a safe, caring and diverse workplace; as well as to taking action to further our commitments to foster inclusion, equity and belonging so employees feel comfortable bringing their full selves to work. Consider making a difference by joining our team. Because together, we arepowering possibility.To learn more, visitbenaroyaresearch.organd connect with us onFacebook,Instagram,Threads, LinkedIn,BlueskyandYouTube.Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. If you need an accommodation or assistance completing the online application, please contact Human Resources at 206-342-6547 or [e-mail] contact information is for accommodation requests only and cannot be used to inquire about the status of applications.