Clinical Research Coordinator at Apex Dermatology and Skin Surgery Center LLC – Mayfield Heights, Ohio

Apex Clinical Research Center, in partnership with Apex Skin, is a rapidly growing clinical research organization committed to advancing dermatologic and medical research through high-quality, compliant trial execution. We are seeking a Clinical Research Coordinator who will be responsible for coordinating industry-sponsored clinical trials, ensuring regulatory compliance, maintaining data integrity, and supporting the successful execution of study protocols.

The Clinical Research Coordinator works closely with Principal Investigators, Sub-Investigators, sponsors, monitors, and research staff to conduct trials in accordance with IRB-approved protocols, Sponsor requirements, Good Clinical Practice (GCP), and established Standard Operating Procedures (SOPs).

Schedule:

• Full-time, Monday through Friday
• Hybrid schedule: 8:00 AM – 4:30 PM (subject to change based on study and site needs)
• Occasional travel required for investigator meetings, training sessions, and clinical staff meetings

Essential Functions:

• 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
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Qualifications:

• 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

Physical Requirements & Work Environment

• Prolonged periods of standing, walking, and sitting
• Frequent use of hands and fingers for documentation, computer entry, and clinical procedures
• Visual acuity sufficient to review medical records, regulatory documents, and electronic systems
• Ability to lift up to 15 pounds frequently and occasionally up to 25 pounds
• Work is performed in a clinical research environment with direct patient interaction and sponsor oversight
• Exposure to clinical specimens and research medications
• Requires strict adherence to GCP, IRB, HIPAA, OSHA, and Apex policies
• May encounter time-sensitive regulatory deadlines and audit activity requiring composure and strong attention to detail

Apex Skin Culture

Apex Skin and Apex Clinical Research Center foster a collaborative, integrity-driven environment grounded in patient safety, regulatory excellence, and teamwork. We value professionals who are detail-oriented, accountable, and committed to advancing medical research while delivering exceptional patient experiences.

Employee Health & Safety Requirements

All patient-facing employees are required to provide proof of a TB test within the past 12 months and an annual flu vaccination as part of Apex’s employee health and safety protocols. The Hepatitis B vaccination series is strongly recommended for clinical staff due to potential occupational exposure risks. Apex complies with federal and Ohio law by providing reasonable accommodations for medical conditions or sincerely held religious beliefs that prevent vaccination. Employees seeking an accommodation should contact Human Resources for more information.

Equal Employment Opportunity Statement

Apex provides equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, sex, national origin, age, disability, or genetics. Apex complies with all applicable federal, state, and local nondiscrimination laws in every location in which the company operates.