Clinical Research Coordinator I/II

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

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