Clinical Research Coordinator

Clinical Research Coordinator Wright State University - 4.2 Dayton, OH Job Details 22 hours ago Qualifications Specimen collection Data preprocessing Vital signs Regulatory documents Informed consent Electronic health records (EHR) management Research ethical considerations Medical procedure assistance Sample preparation Operations coordination planning Assisting with diagnostic tests and procedures Assisting medical staff Mid-level State healthcare regulations Patient safety Research project coordination ICH guidelines Policy & process development Bachelor's degree Clinical data entry Dermatology Informed consent procedures implementation Organizational skills Clinical trial patient safety management Implementing research protocols Patient recruitment Clinical research inspection readiness Patient interaction Research regulatory compliance Data collection Full Job Description 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: 60% — Clinical Trial Coordination and Study Operations Coordinate day-to-day study activities, including study startup, participant scheduling, visit coordination, monitoring visits, and study close-out. Collaborate with investigators, research nurses, regulatory staff, and sponsors to ensure accurate and timely execution of protocol procedures. Integrate research workflows into clinical settings across PTU-affiliated practice locations. Serve as a liaison to investigators, medical staff, ancillary departments, and external partners to support study operations. Ensure participant safety through ongoing communication, visit preparation, and protocol adherence. 25% — Participant Interaction, Enrollment, and Data Collection Conduct participant screening, eligibility verification, and informed consent processes. Support clinical procedures such as vital sign collection, dermatologic assessments, sample collection, and processing (as delegated and trained). Maintain accurate and complete source documentation and complete case report forms or electronic data capture entries in a timely manner. 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.