Clinical Research Coordinator (43640)

About the position

The Clinical Research Coordinator is responsible for overseeing and maintaining all aspects of clinical research trials to ensure adherence to FDA guidelines and study protocols. This role involves subject recruitment, screening, and enrollment, as well as scheduling and conducting study visits per study protocol. The coordinator will directly collect data from subjects, obtain informed consent, and provide patient education and literature. Additionally, the coordinator will maintain source documents, complete and review case report forms (CRFs) for accuracy, and conduct site monitoring visits and audits. Interaction with the Institutional Review Board (IRB) and sponsors is also a key responsibility, along with working directly with Principal Investigators (P.I.) or Sub-Investigator (Sub-I) physicians. The role includes the collection of laboratory specimens, documentation of laboratory and histological procedures, ensuring accurate labeling of slide photos, and documenting lab results with follow-up. The coordinator will file and maintain all study-related documents, document adverse events, and notify the principal investigator and appropriate agencies. They will also notify the sponsor and IRB of any serious adverse events, assist physicians with procedures, take pre and post-treatment pictures, clean, pack, and sterilize instruments, and assist in cleaning rooms. Monitoring the physician's schedule to maintain timely flow, checking voicemail, and triaging calls according to protocol the same day are also part of the role. The coordinator will travel to investigator meetings, participate and contribute in staff meetings, and perform other duties as assigned.

Responsibilities

• Overseeing and maintaining all aspects of clinical research trials to ensure adherence to FDA guidelines and study protocols
• Subject recruitment, screening and enrollment
• Schedules and conducts study visits per study protocol
• Directly collects data from subjects
• Obtains informed consent
• Provides patient education and literature
• Maintains source documents
• Completes and reviews case report forms (CRFs) for accuracy
• Conducts site monitoring visits and audits
• Interacts with IRB (Institutional Review Board) and sponsors
• Works directly with P.I. or Sub-I physicians
• Collects laboratory specimens and documents laboratory and histological procedures
• Ensures accurate labeling of slide photos
• Documents lab results and follows up
• Files and maintains all study-related documents
• Documents adverse events and notifies principal investigator and appropriate agencies
• Notifies sponsor and IRB of any serious adverse events
• Assists physician with all procedures
• Takes pre and post-treatment pictures
• Cleans, packs, and sterilizes instruments
• Assists in cleaning rooms
• Monitors physician's schedule to maintain timely flow
• Checks voicemail and triages calls according to protocol the same day
• Travels to investigator meetings
• Participates and contributes in staff meetings
• Performs other duties as assigned

Requirements

• 2+ years Clinical Research Coordinator experience
• Must have subject recruitment Clinical Trial experience
• Regulatory experience preferred
• Medical Assistant or equivalent training desirable
• CPR Certified
• Knowledge of CFR ICH GCP Guidelines
• Clinical Research Certifications a plus
• Dermatology experience a plus

Nice-to-haves

• Experienced in IRB regulatory submission process and related maintenance documents
• Knowledge of GCP's (Good Clinical Practices)
• Knowledge of Federal Guidelines
• Knowledge of the California Experimental Subject's Bill of Rights
• Knowledge of CFR (code of federal regulations)
• Knowledge of phlebotomy technique
• Knowledge of basic medical assisting techniques