Hybrid Clinical Research Coordinator

at Apex Skin

• Job title: Clinical Research Coordinator
• Job type: Full Time
• Experience level: Junior, Mid level
• Salary: Not specified
• Degree requirement: High School Diploma
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Canton, United States

About the role

• Clinical Research Coordinator responsible for coordinating clinical trials and ensuring regulatory compliance. Conducting patient care activities and maintaining data integrity in accordance with study protocols.

Responsibilities

• Identify, screen, randomize, and enroll patients into IRB-approved clinical trial protocols
• Conduct all trial-related procedures in accordance with IRB-approved protocols, Sponsor requirements, SOPs, and Good Clinical Practice (GCP) guidelines
• Perform direct patient care activities including informed consent, physical assessments, blood draws, medication administration, and ECG procedures
• Ensure accurate and timely data entry into Sponsor Electronic Data Capture (EDC) systems and maintain clean, complete study data
• Oversee site initiation activities and support study startup, maintenance, and close-out processes
• Prepare and submit regulatory documentation required for study startup and ongoing trial maintenance
• Maintain and update IRB submissions, amendments, and continuing reviews, resolving regulatory issues promptly
• Create and maintain up-to-date source documentation (paper-based and/or electronic source) for each study
• Review audit findings with the Principal Investigator and Director of Clinical Operations and implement corrective actions as needed
• Identify, document, and report Adverse Events (AEs), Serious Adverse Events (SAEs), protocol deviations, and violations accurately and in a timely manner

Requirements

• High school diploma or equivalent required; Bachelor’s or Associate degree preferred
• Minimum of two years of experience coordinating industry-sponsored clinical trials
• At least one year of experience in a medical, hospital, or research setting
• Strong written and verbal communication skills
• Ability to frequently lift up to 15 pounds and occasionally transport up to 25 pounds
• One year of laboratory coordination experience
• RN certification or certification in Phlebotomy and/or IV infusions preferred
• Experience preparing and submitting IRB applications, including new studies and amendments
• Knowledge of regulatory compliance, GCP standards, and Sponsor expectations.

Benefits

• Health & safety protocols for patient-facing employees
• Reasonable accommodations for medical conditions or religious beliefs