Clinical Research Coordinator (2 positions), Pharmacology Translational Unit

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
• Clinically 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.

• 10% - Compliance, Documentation, and Monitoring
• Support compliance with federal, state, institutional, and sponsor requirements.
• Organize and maintain essential regulatory and study documentation.
• Prepare for monitoring visits, audits, and sponsor inspections.
• Afford assistance 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.