Location: Cleveland, OH
Cap-Exempt H-1B Position — No lottery required
Coordinates the compliant implementation and conduct of human subject research projects typically of low workload and low complexity. **Responsibilities:** - Assists with the coordination, implementation, and conduct of research projects ensuring adherence to research protocol requirements which may include: maintenance of regulatory documents and binders, data management, IRB submissions and communication of such to the research team. - May be responsible for reporting/completion of Serious Adverse Events and/or safety log as defined per protocol as they occur and completion of Food and Drug Administration (FDA) and sponsor forms in accordance with GCP guidelines as applicable. - Communicates with sponsors, monitors, research personnel to ensure all aspects of study compliance. - Collaborates with study team to schedule pre-site selection visits, site initiation visits, webinars, monitoring and close-out visits. - May collaborate with primary investigator, sponsor and research staff to plan, conduct and evaluate project protocols, including research subject recruitment. - Monitors and reports project status. - Completes regulatory documents, data capture and monitoring plans. - Assists with completion of protocol related activities. - As delegated, may be required to attain and maintain clinical competencies for unlicensed caregivers such as phlebotomy, vital signs, ECG, POC testing and other testing as required. - Monitors research data to maintain quality. - Understands basic concepts of study design. - Demonstrates comprehension of assigned research protocols. - Develops and maintains knowledge of research protocol to coordinate the comprehensive and compliant execution of assigned protocols. - Assists with preparation for audits and response to audits. - May assist in the development and maintenance of research tools, such as spreadsheets, questionnaires and/or brochures. - Maintains study personnel certification records (License, CV, CITI). - Maintains profess