Clinical Research Coordinator — Regulatory & Trials Lead

CENTER FOR DERMATOLOGY; Washington (District of Columbia); On-site; USD 65,000 - 95,000; Full time

Job summary

CENTER FOR DERMATOLOGY is seeking a skilled Clinical Research Coordinator to oversee planning, coordination, and execution of clinical trials in Washington, DC and Annapolis, MD. The role emphasizes regulatory affairs and data quality throughout all trial phases.

You will coordinate patient recruitment, safety monitoring, data collection, and regulatory submissions while supervising staff and ensuring strict adherence to FDA regulations, GCP, HIPAA, and CDISC standards.

Qualifications

• Experience supervising in a clinical research setting with regulatory compliance.
• Strong knowledge of FDA regulations, ICH GCP, HIPAA privacy rules.
• Background in nursing or phlebotomy is highly desirable; ICH GCP certificate preferred.
• Experience with data management systems and EMR platforms, CDISC standards.

Responsibilities

• Coordinate and manage all aspects of clinical trials, including patient recruitment, scheduling, and follow-up procedures.
• Ensure adherence to FDA regulations, ICH GCP, and HIPAA guidelines to maintain compliance.
• Review and verify study documentation for accuracy and regulatory compliance.
• Monitor patient safety by conducting vital signs, phlebotomy, and tracking adverse events.
• Manage data collection, entry, and management using EMR systems and CDISC standards.
• Supervise clinical staff involved in trial activities and ensure protocol adherence.
• Oversee clinical laboratory procedures and sample handling with lab personnel.
• Conduct patient monitoring visits and review medical histories for proper documentation.
• Prepare reports for regulatory submissions and support audit readiness.

Skills

Regulatory affairs

Clinical trial management

GCP compliance

Phlebotomy awareness

Medical terminology

Education

Nursing background

Phlebotomy certification

ICH GCP certification

Tools

EMR systems

CDISC data standards

Job description

CENTER FOR DERMATOLOGY is seeking a skilled Clinical Research Coordinator to oversee planning, coordination, and execution of clinical trials in Washington, DC and Annapolis, MD. The role emphasizes regulatory affairs and data quality throughout all trial phases.

You will coordinate patient recruitment, safety monitoring, data collection, and regulatory submissions while supervising staff and ensuring strict adherence to FDA regulations, GCP, HIPAA, and CDISC standards.