Clinical Research Coordinator 251768

Job Description

Qualifications

Benefits

Responsibilities

• •The Clinical Research Coordinator (CRC) is responsible for the daily management and execution of clinical trials at the research site, working under the guidance of the Principal Investigator (PI)
• •The CRC ensures that studies are conducted in accordance with the study protocol, ICH-GCP guidelines, FDA regulations, and institutional SOPs
• •Study Startup & Regulatory: Assist with protocol review, IRB submissions, and preparation of regulatory binders
• •Participant Recruitment & Screening: Identify, recruit, and screen potential participants against inclusion/exclusion criteria
• •Informed Consent: Conduct the informed consent process, ensuring participants understand study requirements, risks, and benefits
• •Study Visits & Procedures: Coordinate and conduct study visits, perform study procedures (e.g., ECGs, vitals), and manage participant follow-up
• •Data Management: Collect, record, and enter accurate source data into Electronic Data Capture (EDC) systems in a timely manner; resolve queries
• •Specimen Management: Collect, process, label, store, and ship laboratory specimens according to the protocol and IATA regulations
• •Safety & Compliance: Monitor participant safety, record adverse events (AEs), and report serious adverse events (SAEs) promptly to the PI and sponsor
• •Investigational Product (IP): Oversee proper receipt, storage, dispensing, and accountability of study drugs/devices
• •Site Visits: Host sponsor monitoring visits