Clinical Trials Coordinator: Patient‑Focused & Compliant

Responsibilities

• •patient safety, data integrity, and protocol adherence
• •Study Initiation & Planning: Assist with site feasibility assessments, attend investigator meetings, and prepare the Investigator Site File (ISF)
• •Subject Recruitment & Screening: Identify, screen, and recruit study participants based on inclusion/exclusion criteria
• •Informed Consent Process: Obtain informed consent from subjects under the guidance of the PI, ensuring they understand the study procedures, risks, and benefits
• •Study Visits & Procedures: Schedule and conduct study visits, perform study-specific procedures (e.g., vital signs, ECGs, blood draws) as per protocol
• •Data Collection & Management: Accurately collect and enter patient data into Electronic Data Capture (EDC) systems, ensuring source document accuracy and resolution of queries in a timely manner
• •Regulatory Compliance: Maintain regulatory binders, submit documents to the IRB (initials, amendments, renewals), and report Adverse Events (AEs) and Serious Adverse Events (SAEs)
• •Investigational Product (IP) Management: Oversee the receipt, storage, dispensing, and accountability of investigational products
• •Lab Management: Process, store, and ship laboratory specimens according to protocol requirements
• •Liaison Duties: Act as the main contact for sponsors, Clinical Research Associates (CRAs), and vendors during monitoring visits and audits
• •7 more items(s)