Clinical Research Coordinator 252588 (Framingham)

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. The CRC acts as a liaison between the PI, study participants, sponsors, and the Institutional Review Board (IRB) to ensure participant safety and data integrity.

Key Responsibilities

• 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