Clinical Research Coordinator I… at InBios… · Seattle

Summary: InBios International, Inc. is a mission-focused biotech company developing diagnostic tools that combat infectious diseases worldwide. They are seeking a temporary, part-time Clinical Research Coordinator to support clinical studies and international product registration, ensuring compliance with regulatory requirements and monitoring study protocols. Responsibilities: - Clinical Site Monitoring - Under the direction of the Project Manager assist in the maintenance of regulatory binders and Institutional Review Board (IRB) submissions - Monitor clinical study to ensure that all participant records entered into the electronic data capture system are accurate and follow the clinical protocol and source documents - Participate in Site Initiation training (SIV), monitor study compliance, and assist with study closeout - Ensure that participants enrolled in the study meet the inclusion/exclusion criteria - Monitor and report protocol deviations and adverse events in a timely manner - Participate in study site close-out - Product Registrations (International) - Identify regulatory requirements for product registrations worldwide - Review analytical and clinical data against country regulatory requirements and identify gaps that need to be filled to obtain product registration - Assist in the preparation of technical files in compliance with IVDR Required Qualifications: - Bachelor's degree in a scientific discipline - Strong attention to detail, excellent written and verbal communication, and proficiency with technology (e.g., MS Office, Electronic Database Systems) - Knowledge of ICH GCP guidelines - GCP certification - Entry-level knowledge of IVDR requirements for medical devices Preferred Qualifications: - 1- to 3-year experience in project management - Certified Clinical Research Associate credential Required Skills: Clinical Practice (GCP), GCP certification, IVDR requirements, Electronic Database Systems, MS Office, Clinical Research Coordination Benefits: Medical, dental, vision, life & disability insurance, 401(k) + Roth IRA + FSA, Prorated paid holidays and sick time as applicable to term of employment and work schedule in accordance with policies stated in the Company’s employee handbook., Supportive, mission-driven culture