The Clinical Research Coordinator I works independently providing study coordination, screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents study information at regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

• Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
• Schedules patients for research visits and procedures.
• In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
• Maintains accurate source documents related to all research procedures.
• Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
• Schedules and participates in monitoring and auditing activities.
• Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
• Notifies direct supervisor about concerns regarding data quality and study conduct.
• Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
• May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• Participates in required training and education programs

Requirements:

• High School Diploma/GED required. Bachelor's Degree preferred.
• 1 year Clinical research related experience required.

Preferred Skills:

• Proven ability to develop and maintain relationships with key community organizations and stakeholders to support and promote community-based research initiatives.
• Experience representing programs at community events, conferences, health fairs, and other outreach activities to build partnerships, enhance visibility, and support participant recruitment efforts.
• Strong organizational skills to coordinate specific aspects of program planning and research implementation, ensuring adherence to timelines and achievement of defined outcomes.
• Ability to perform general office duties including photocopying, preparing informational packets, answering phones, and maintaining organized filing systems.
• Competence in assisting with data collection, conducting basic analysis, and contributing to the preparation of research reports and summaries.
• Strong written communication skills to draft professional emails, documents, and correspondence as needed.
• Physical ability to lift and carry items weighing up to 20 pounds.
• Flexibility to work occasional evenings and weekends based on program or research needs.