Clinical Research Coordinator

Job Summary/Basic Function: The Clinical Research Coordinator (CRC) supports the planning, implementation, execution, and completion of clinical and translational research studies conducted within the Pharmacology Translational Unit (PTU). The CRC works collaboratively with investigators, research nurses, sponsors, contract research organizations, and external clinical partners to ensure that research protocols are conducted in compliance with federal regulations, Good Clinical Practice (GCP), institutional policies, and study-specific requirements. The CRC is responsible for participant scheduling, informed consent administration, data collection, source documentation, sample processing, monitoring visit preparation, and supporting overall study operations. This role requires strong organizational skills, attention to detail, and the ability to integrate research workflows within clinical settings. Minimum Qualifications Bachelor’s degree with 1 year of experience in clinical research OR in a clinical environment with direct interaction with patients, families, and healthcare staff. OR equivalent combination of education and experience. Excellent oral and written communication skills. Ability to work independently and collaboratively while maintaining regulatory and protocol timelines. Strong organizational skills and a high level of attention to detail. Demonstrated ability to prioritize responsibilities, manage competing deadlines, and troubleshoot operational issues. Preferred Qualifications Experience in dermatology research or other outpatient specialty research settings. Knowledge of clinical research regulatory requirements (FDA, ICH-GCP, OHRP, IRB). Experience supporting sponsor-initiated or investigator-initiated trials in an academic setting. Familiarity with clinical billing practices and workflow coordination with clinic and hospital departments. Experience with electronic data capture systems and electronic medical records. Essential Functions and percent of time (cont'd): 10% — Compliance, Documentation, and Monitoring Support Ensure compliance with federal, state, institutional, and sponsor requirements. Organize and maintain essential regulatory and study documentation. Prepare for monitoring visits, audits, and sponsor inspections. Assist with query resolution and data clean-up for interim and final database locks. 5% — Special Projects and PTU Support Assist with quality assurance activities, workflow improvements, and study-related process development. Contribute to team meetings, training sessions, and departmental initiatives. Other duties as assigned. #J-18808-Ljbffr