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Job Description
Detailed Job DescriptionClinical Research Coordinator/Nurse Coordinator with over 2 years of experience supporting and coordinating Phase I-IV clinical trials involving patients and healthy volunteers.
Experienced in managing study activities from startup through closeout while ensuring compliance with FDA regulations, ICH-GCP guidelines, SOPs, and study protocols.
Responsible for coordinating subject recruitment, screening, enrollment, informed consent, and retention activities.
Independently conducts subject visits and performs protocol-required procedures including vital signs, ECGs, height, weight measurements, pregnancy testing, specimen collection, and safety assessments while ensuring participant safety and comfort throughout the study process.
Maintains accurate and timely documentation in EDC and IRT systems, completes case report forms, updates source documents, tracks adverse events, and ensures all study data is entered according to protocol and sponsor timelines.
Coordinates with investigators, sponsors, IRBs, laboratory staff, and cross-functional site teams to support smooth clinical trial operations.
Ensures IRB approvals and regulatory documentation are maintained throughout the study lifecycle.
Participates in site initiation visits, monitoring visits, and sponsor meetings while supporting protocol training and compliance activities.
Experienced in investigational product accountability, patient scheduling, follow-up communication, and maintaining study records with strong attention to detail and data integrity.
Possesses strong knowledge of clinical research processes including GCP, informed consent procedures, safety monitoring, protocol compliance, and regulatory requirements.
Demonstrates excellent organizational, communication, problem-solving, and interpersonal skills with the ability to work independently and manage multiple studies simultaneously.