Clinical Research Coordinator I/II

Benaroya Research Institute•Seattle, WA

13d•$26 - $45

About The Position

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.

Requirements

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)
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
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

Nice To Haves

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

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
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
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