Clinical Research Coordinator I/II
$25.66 - $37.21 per hourBenaroya institute
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
- 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
- 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
- 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
- Clinical Research Coordinator I - $25.66 to $37.21 hourly
- Clinical Research Coordinator II - $30.00 to $44.69 hourly
- 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
Vacancy posted 15 hours ago
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